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    Clinical Trial Results:
    A Randomised, Double-blind, Placebo-Controlled, Parallel-Group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia

    Summary
    EudraCT number
    		 2011-002048-29
    Trial protocol
    		 SK   RO  
    Global end of trial date
    03 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jun 2018
    First version publication date
    21 Jun 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RGH-MD-06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01412060
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Forest Laboratories, LLC, an Allergan Affiliate
    Sponsor organisation address
    5 Giralda Farms, Madison, United States, NJ 07940
    Public contact
    Clinical Trials Registry Team, Allergan plc, 001 877‐277‐8566, IR-CTRegistration@allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan plc, 001 862-261-7000, IR-CTRegistration@Allergan.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 393
    Country: Number of subjects enrolled
    India: 143
    Country: Number of subjects enrolled
    Romania: 87
    Country: Number of subjects enrolled
    Slovakia: 47
    Country: Number of subjects enrolled
    Ukraine: 95
    Worldwide total number of subjects
    765
    EEA total number of subjects
    134
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    765
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 765 participants were enrolled and received cariprazine in Run-in Phase; 751 of these, had at least 1 postbaseline Positive and Negative Syndrome Scale (PANSS) evaluation and 364 entered Stabilization Phase. Only 200 participants who completed Open-label phase, received either placebo (n=99) or cariprazine (n=101) in Double-Blind Phase.

    Pre-assignment
    Screening details
    		 A screening phase of up to 7 days, followed by an 8-week open-label Run- in Phase (RIP), a 12-week open-label Stabilisation Phase (SP), a variable length (26 to 72 weeks) Double-blind Phase (DBP) and 4-week safety follow-up phase.

    Period 1
    Period 1 title
    Open-label Run-in Period (RIP)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cariprazine - Open-label Phase
    Arm description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next 14 weeks of this 20-week Open-label Phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 1.5 mg nontrade capsule
    Investigational medicinal product code
    Other name
    RGH-188
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cariprazine (nontrade capsules), supplied as 1.5 mg capsules were administered orally as a starting dose on Day 1 of Run-in Phase.

    Investigational medicinal product name
    Cariprazine 3 mg nontrade capsule
    Investigational medicinal product code
    Other name
    RGH-188
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cariprazine (nontrade capsules), supplied as 3 mg capsules, were administered orally once a day in flexible doses of 3-9 mg for first 6 weeks in Run-in Phase followed by a fixed dose of 3, 6, 9 mg/day for the next 2 weeks of this 20-week Open-label Phase.

    Number of subjects in period 1
    		Cariprazine - Open-label Phase
    Started
    765
    Completed
    418
    Not completed
    347
         Withdrawal of Consent
    117
         Adverse Event
    86
         Other Miscellaneous Reasons
    19
         Lost to follow-up
    32
         Insufficient Therapeutic Response
    66
         Protocol deviation
    27
    Period 2
    Period 2 title
    Period Between RIP and SP
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cariprazine - Open-label Phase
    Arm description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next14 weeks of this 20-week Open-label Phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 3 mg nontrade capsule
    Investigational medicinal product code
    Other name
    RGH-188
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cariprazine (nontrade capsules), supplied as 3 mg capsules, were administered orally once a day in flexible doses of 3-9 mg for first 6 weeks in Run- in Phase followed by a fixed dose of 3, 6, 9 mg/day for the next 14 weeks of this 20-week Open-label Phase.

    Number of subjects in period 2
    		Cariprazine - Open-label Phase
    Started
    418
    Completed
    364
    Not completed
    54
         Withdrawal of Consent
    1
         Adverse Event
    4
         Lost to follow-up
    5
         Other Miscellaneous Reasons
    23
         Insufficient Therapeutic Response
    19
         Protocol deviation
    2
    Period 3
    Period 3 title
    Open-label Stabilization Period (SP)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cariprazine - Open-label Phase
    Arm description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next14 weeks of this 20-week Open-label Phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 3 mg nontrade capsule
    Investigational medicinal product code
    Other name
    RGH-188
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cariprazine (nontrade capsules), supplied as 3 mg capsules, were administered orally once a day in a fixed dose of 3, 6, 9 mg, for 12 weeks of the Stabilization Period.

    Number of subjects in period 3
    		Cariprazine - Open-label Phase
    Started
    364
    Completed
    264
    Not completed
    100
         Withdrawal of Consent
    40
         Adverse Event
    9
         Lost to follow-up
    9
         Other Miscellaneous Reasons
    19
         Insufficient Therapeutic Response
    9
         Protocol deviation
    14
    Period 4
    Period 4 title
    Period Between SP and DBP
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cariprazine - Open-label Phase
    Arm description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next14 weeks of this 20-week Open-label Phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 3 mg nontrade capsule
    Investigational medicinal product code
    Other name
    RGH-188
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cariprazine (nontrade capsules), supplied as 3 mg capsules, were administered orally once a day in a fixed dose of 3, 6, 9 mg, for 12 weeks of the Stabilization Period.

    Number of subjects in period 4
    		Cariprazine - Open-label Phase
    Started
    264
    Completed
    200
    Not completed
    64
         Withdrawal of Consent
    2
         Did Not Met Criteria to Enter Next Phase
    4
         Lost to follow-up
    1
         Other Miscellaneous Reasons
    55
         Protocol deviation
    2
    Period 5
    Period 5 title
    Double-blind Treatment Period (DBP)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo - Double-blind Treatment Phase
    Arm description
    		 Participants received placebo orally once a day for 26 to 72 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo nontrade capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants were administered matching placebo orally once a day for 26 to 72 weeks.

    Arm title
    		 Cariprazine - Double-blind Treatment Phase
    Arm description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cariprazine 3 mg nontrade capsule
    Investigational medicinal product code
    Other name
    RGH-188
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cariprazine (nontrade capsules), supplied as 1.5 mg capsules and 3 mg capsules, were administered orally once a day at a fixed dose of 3, 6. 9 mg up to 26 to 72 weeks.

    Number of subjects in period 5
    		Placebo - Double-blind Treatment Phase Cariprazine - Double-blind Treatment Phase
    Started
    99
    101
    Completed
    16
    18
    Not completed
    83
    83
         Withdrawal of Consent
    10
    15
         Relapse
    47
    25
         Adverse Event
    5
    6
         Lost to follow-up
    6
    5
         Other Miscellaneous Reasons
    11
    27
         Protocol deviation
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cariprazine - Open-label Phase
    Reporting group description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next 14 weeks of this 20-week Open-label Phase.

    Reporting group values
    		 Cariprazine - Open-label Phase Total
    Number of subjects
    		 765 765
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 765 765
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.4 ( 10.4 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 221 221
        Male
    		 544 544
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 37 37
        Not Hispanic or Latino
    		 728 728
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 149 149
        Native Hawaiian or Other Pacific Islander
    		 1 1
        Black or African American
    		 313 313
        White
    		 299 299
        Other
    		 3 3
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 78.07 ( 20.10 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 170.98 ( 9.95 ) -
    Body Mass Index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 26.50 ( 5.63 ) -
    Waist circumference
    Units: cm
        arithmetic mean (standard deviation)
    		 90.39 ( 15.34 ) -

    End points

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    End points reporting groups
    Reporting group title
    Cariprazine - Open-label Phase
    Reporting group description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next 14 weeks of this 20-week Open-label Phase.
    Reporting group title
    Cariprazine - Open-label Phase
    Reporting group description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next14 weeks of this 20-week Open-label Phase.
    Reporting group title
    Cariprazine - Open-label Phase
    Reporting group description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next14 weeks of this 20-week Open-label Phase.
    Reporting group title
    Cariprazine - Open-label Phase
    Reporting group description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the next14 weeks of this 20-week Open-label Phase.
    Reporting group title
    Placebo - Double-blind Treatment Phase
    Reporting group description
    		 Participants received placebo orally once a day for 26 to 72 weeks.

    Reporting group title
    Cariprazine - Double-blind Treatment Phase
    Reporting group description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.

    Primary: Time From Baseline to the First Symptom Relapse During the Double-blind Phase

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    End point title
    		 Time From Baseline to the First Symptom Relapse During the Double-blind Phase
    End point description
    Relapse:meeting ≥1 of the criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by≥30% who scored ≥50or≥10-point rise who scored <50 at randomisation;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week20;4-deliberate self-injury/aggressive behaviour;5-suicidal/homicidal ideation:clinically significant;6-score of >4 on PANSS items:P1,P2,P3,P6,P7,G8orG14. Second assessment not performed based on Investigator’s decision. PANSS:30-item scale. Each item scored on 7-point scale. Total score:30-210. Lower score:fewer symptoms. CGI-S:7-point scale,measures severity of participant's illness in comparison to others with same diagnosis. Lower score:less severe illness. 25th percentile, 95% CI based on Kaplan-Meier estimates reported. All who received at least 1 dose and had at least 1 post-randomisation PANSS/CGI-S during DBP. 99999: Upper Limit of CI not reached due to insufficient events.
    End point type
    Primary
    End point timeframe
    Up to 34 Weeks and Bi-Weekly thereafter until Week 92
    End point values
    		 Placebo - Double-blind Treatment Phase Cariprazine - Double-blind Treatment Phase
    Number of subjects analysed
    99
    101
    Units: days
        number (confidence interval 95%)
    92 (44 to 151)
    224 (99 to 99999)
    Statistical analysis title
    		 cariprazine vs placebo
    Comparison groups
    Placebo - Double-blind Treatment Phase v Cariprazine - Double-blind Treatment Phase
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 0.73

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose until 30 days after last dose of investigational product [Open-Label (Up to 184 days) and Double-Blind (Up to 536 days)]
    Adverse event reporting additional description
    All randomised participants who received at least 1 dose of investigational product and 1 dose of double-blind product and had at least 1 post-randomisation assessment of PANSS or CGI-S during the open-label phase. Adverse events data was reported in periods as per the treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Cariprazine - Open-label Phase
    Reporting group description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20-week Open-label Phase.

    Reporting group title
    Placebo - Double-blind Treatment Phase
    Reporting group description
    		 Participants received placebo orally once a day for 26 to 72 weeks.

    Reporting group title
    Cariprazine - Double-blind Treatment Phase
    Reporting group description
    		 Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.

    Reporting group title
    Open-label - Safety Follow-up Phase
    Reporting group description
    		 Participants received no treatment during the 4 weeks Safety Follow-up Phase.

    Reporting group title
    Placebo - Safety Follow-up
    Reporting group description
    		 Participants received no treatment during the 4 weeks Safety Follow-up Phase.

    Reporting group title
    Cariprazine - Safety Follow-up Phase
    Reporting group description
    		 Participants received no treatment during the 4 weeks Safety Follow-up Phase.

    Serious adverse events
    		 Cariprazine - Open-label Phase Placebo - Double-blind Treatment Phase Cariprazine - Double-blind Treatment Phase Open-label - Safety Follow-up Phase Placebo - Safety Follow-up Cariprazine - Safety Follow-up Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    50 / 765 (6.54%)
    14 / 99 (14.14%)
    14 / 101 (13.86%)
    6 / 765 (0.78%)
    2 / 99 (2.02%)
    0 / 101 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Intentional product misuse
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug ineffective
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Social stay hospitalisation
         subjects affected / exposed
    2 / 765 (0.26%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Victim of crime
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    19 / 765 (2.48%)
    7 / 99 (7.07%)
    5 / 101 (4.95%)
    3 / 765 (0.39%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    4 / 19
    3 / 7
    0 / 5
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    10 / 765 (1.31%)
    2 / 99 (2.02%)
    2 / 101 (1.98%)
    3 / 765 (0.39%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 2
    0 / 2
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    5 / 765 (0.65%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia, paranoid type
         subjects affected / exposed
    3 / 765 (0.39%)
    0 / 99 (0.00%)
    2 / 101 (1.98%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic behaviour
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Restlessness
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Psychiatric evaluation
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foreign body
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extrapyramidal disorder
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Middle ear effusion
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haematemesis
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 765 (0.13%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 765 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cariprazine - Open-label Phase Placebo - Double-blind Treatment Phase Cariprazine - Double-blind Treatment Phase Open-label - Safety Follow-up Phase Placebo - Safety Follow-up Cariprazine - Safety Follow-up Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    425 / 765 (55.56%)
    28 / 99 (28.28%)
    35 / 101 (34.65%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    Investigations
    Weight increased
         subjects affected / exposed
    49 / 765 (6.41%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    49
    0
    0
    0
    0
    0
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    148 / 765 (19.35%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    203
    0
    0
    0
    0
    0
    Extrapyramidal disorder
         subjects affected / exposed
    55 / 765 (7.19%)
    3 / 99 (3.03%)
    6 / 101 (5.94%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    70
    4
    6
    0
    0
    0
    Headache
         subjects affected / exposed
    92 / 765 (12.03%)
    7 / 99 (7.07%)
    8 / 101 (7.92%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    112
    7
    10
    0
    0
    0
    Tremor
         subjects affected / exposed
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    8 / 101 (7.92%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    8
    0
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    39 / 765 (5.10%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    47
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    46 / 765 (6.01%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    54
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    48 / 765 (6.27%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    61
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 765 (0.00%)
    5 / 99 (5.05%)
    4 / 101 (3.96%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    5
    4
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    39 / 765 (5.10%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    47
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    110 / 765 (14.38%)
    8 / 99 (8.08%)
    8 / 101 (7.92%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    155
    11
    14
    0
    0
    0
    Restlessness
         subjects affected / exposed
    70 / 765 (9.15%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    90
    0
    0
    0
    0
    0
    Schizophrenia
         subjects affected / exposed
    0 / 765 (0.00%)
    6 / 99 (6.06%)
    4 / 101 (3.96%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    6
    4
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 765 (0.00%)
    5 / 99 (5.05%)
    8 / 101 (7.92%)
    0 / 765 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    5
    11
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Sep 2011
    Amendment#1. 1. Added 4 additional weeks in the stabilization phase. 2. Increased the number of participants to be enrolled from 700 to 900. 3. Allowed conditional use of selective serotonin reuptake inhibitors (SSRIs). 4. Made minor editorial updates.
    27 Aug 2012
    Amendment#2 1. Revised exclusive criterion #14 to allow some prior participated participants in cariprazine studies. 2. Revised exclusive criterion #25 to be consistent within RGH program. 3. Made minor editorial updates.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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