Clinical Trial Results:
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Bipolar I Disorder
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Summary
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EudraCT number |
2012-004334-42 |
Trial protocol |
HU |
Global end of trial date |
18 Nov 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Dec 2017
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First version publication date |
18 Dec 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
31-08-252
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01710709 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Sponsor organisation address |
2440 Research Boulevard, Rockville, Maryland, United States, 20850
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Public contact |
Senior Director, Global Clinical Development, Joan Amatniek, MD, MS, 609 512-4464, joan.amatniek@otsuka-us.com
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Scientific contact |
Senior Director, Global Clinical Development, Joan Amatniek, MD, MS, 609 512-4464, joan.amatniek@otsuka-us.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Dec 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Nov 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Nov 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The trial evaluated effectiveness via assessment of safety and tolerability (primary objective) and efficacy (secondary objective) of aripiprazole IM depot as measured by maintenance of stability in subjects with bipolar I disorder.
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Protection of trial subjects |
The study was conducted according to the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline and the applicable local laws and regulatory requirements of the countries in which the trial was conducted. Informed consent was obtained from all subjects in writing before any trial related procedures were performed. Prior to start, copies of the protocol, any amendments, and the informed consent form (ICF) were reviewed and approved by the governing institutional review broad (IRB) or independent ethics committee (IEC). Essential information was fully explained in layman's language to the subject by the investigator or a qualified designee.
Note: All subjects were 18 years and older at time of informed consent.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Nov 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 28
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Country: Number of subjects enrolled |
France: 5
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Country: Number of subjects enrolled |
Hungary: 4
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Country: Number of subjects enrolled |
Canada: 3
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Country: Number of subjects enrolled |
Korea, Democratic People's Republic of: 6
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Country: Number of subjects enrolled |
Romania: 10
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Country: Number of subjects enrolled |
United States: 322
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Country: Number of subjects enrolled |
Japan: 75
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Country: Number of subjects enrolled |
Taiwan: 1
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Country: Number of subjects enrolled |
Malaysia: 10
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Worldwide total number of subjects |
464
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EEA total number of subjects |
47
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
458
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From 65 to 84 years |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants who had completed trial 31-08-250 (rollover - 85 participants) and who had not participated (de novo - 379 participants) were enrolled in the IM Depot Maintenance Phase and received at least 1 dose of IMP . | ||||||||||||||||||||||
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Pre-assignment
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Screening details |
For de novo participants, screening took place from Days -42 to -2 | ||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||
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Arms
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Arm title
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Phase C: Open-label IM Depot Maintenance Phase | ||||||||||||||||||||||
Arm description |
All De novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. For participants who completed Trial 31-08-250 (some of whom had received double-blind placebo), the use of supplemental oral aripiprazole for the first ≤ 2 weeks was at the investigator's discretion based on the clinical status of the participant. Administration of rescue therapy was recommended for participants who did not meet stability criteria during the IM Depot Maintenance Phase, unless in the investigator’s judgment withdrawal from the trial was considered more appropriate. | ||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||
Investigational medicinal product name |
aripiprazole
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Investigational medicinal product code |
OPC-14597
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Other name |
Abilify Maintena
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Prior to injection, vials of aripiprazole IM depot 400 mg were reconstituted with a designated quantity of sterile water for injection. Participants received the drug through intramuscular route. The dosage details are given below:
Initially 400 mg, every 4 weeks for ≤ 52 weeks; flexible dosing with 300 mg and 400 mg was permitted as often as necessary during the treatment period. De novo participants also received oral aripiprazole during the first 2 weeks to maintain therapeutic levels
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Baseline characteristics reporting groups
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Reporting group title |
Phase C: Open-label IM Depot Maintenance Phase
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Reporting group description |
All De novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. For participants who completed Trial 31-08-250 (some of whom had received double-blind placebo), the use of supplemental oral aripiprazole for the first ≤ 2 weeks was at the investigator's discretion based on the clinical status of the participant. Administration of rescue therapy was recommended for participants who did not meet stability criteria during the IM Depot Maintenance Phase, unless in the investigator’s judgment withdrawal from the trial was considered more appropriate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Phase C: Open-label IM Depot Maintenance Phase
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Reporting group description |
All De novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. For participants who completed Trial 31-08-250 (some of whom had received double-blind placebo), the use of supplemental oral aripiprazole for the first ≤ 2 weeks was at the investigator's discretion based on the clinical status of the participant. Administration of rescue therapy was recommended for participants who did not meet stability criteria during the IM Depot Maintenance Phase, unless in the investigator’s judgment withdrawal from the trial was considered more appropriate. | ||
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End point title |
Number of participants with Adverse Events [1] | ||||||||||||||||||||||||
End point description |
An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP). Any adverse events (AEs) were recorded from the signing of informed consent onward. At each visit, the occurrences of AEs and the participant's recorded AE information were assessed. AEs were assessed as a criteria for safety and tolerability.
Analysis Population Description:
IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. TEAEs = Treatment-emergent adverse events (used in the result table).
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End point type |
Primary
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End point timeframe |
At baseline, Phase C trial weeks 1 to 52/early termination (ET) and post-treatment follow-up
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was specified for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Injection Site Pain Measured by mean Visual Analog Scale (VAS) scores [2] | ||||||||||||||||||||||||||||||||||||
End point description |
Injection-site pain was evaluated by mean visual analog scale (VAS) scores as reported by the participant after each injection at visits where an injection occurred. The degree of pain at the most recent injection site was measured by VAS. The rating scale ranged from 0 (no pain) to 100 (unbearably painful). Participants were followed for 1 hour post-injection and then VAS was completed. Injection evaluations were completed on the same day that the injection was administered
Analysis Population Description
All participants who received at least one dose of aripiprazole IM depot. It is equivalent to safety set (SAF). Number analyzed (n) = Total number of participants with at least one observation of the given parameter (used in result table)
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End point type |
Primary
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End point timeframe |
At baseline and Phase C trial weeks 4, 8, 12 to 48
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was specified for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Number of participants with Clinically Significant Abnormal Laboratory Test results [3] | ||||||||||||||||
End point description |
Standard safety variables to be analyzed were included clinical laboratory tests.
Analysis Population Description
All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.
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End point type |
Primary
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End point timeframe |
At baseline and Phase C trial week 52/ET
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was specified for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of Participants With Clinically Significant Abnormal Vital Signs [4] | ||||||||||||||||||
End point description |
Vital sign measurements included body temperature, systolic and diastolic blood pressure, and heart rate.
Analysis Population Description:
IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.
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End point type |
Primary
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End point timeframe |
At baseline, Phase C trial weeks 1 to 52/early termination (ET) and post-treatment follow-up
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was specified for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs) [5] | ||||||||||||||||
End point description |
Twelve-lead ECGs were recorded at specified visits. For each time point, three 12-lead ECG recordings were obtained approximately 5 minutes apart. Additional 12-lead ECGs were permitted to be obtained at the investigator's discretion and were always obtained in the event of an early termination. The ECGs were evaluated at the investigational site to determine the participant's eligibility and to monitor safety during the trial.
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End point type |
Primary
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End point timeframe |
At baseline and Phase C trial week 52/ET
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was specified for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Extrapyramidal Symptoms (EPS) assessed by Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Used only in Japan), and Barnes Akathisia Rating Scale (BARS) [6] | ||||||||||||||||||||||||
End point description |
Extrapyramidal symptoms were evaluated by calculating mean change from baseline in the following:
AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Each item was rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness/severe distress). The SAS consisted of a list of 10 symptoms of parkinsonism. Each item was rated on a 5-point scale, with a score of 1 representing absence of symptoms, and a score of 5 representing a severe condition. The SAS Total Score is the sum of the scores for all 10 items. The DIEPSS was a rating scale for assessing extrapyramidal symptoms that consisted of 8 items for assessing individual symptoms and 1 item for assessing general severity—9 items in all. Each item was assessed on a scale of 0 (no symptoms, normal) to 4 (severe). The BARS consisted of 4 items related to akathisia.
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End point type |
Primary
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End point timeframe |
At baseline and Phase C trial weeks 4, 8, 12 to 52/ET
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was specified for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Assessment of Risk of Suicidal Events and Classification by Completion of Columbia Suicide Severity Rating Scale (C-SSRS) [7] | ||||||||||||||||||||
End point description |
Suicidality was monitored by using the C-SSRS at every visit. The C-SSRS scale consisted of a screening/baseline evaluation that assessed the participant's lifetime experience and experience over the last 90 days with suicide events and suicidal ideation and a postbaseline/ "Since Last Visit" evaluation that focused on suicidality since the last trial visit.
Analysis Population Description:
All participants who received at least 1 dose of aripiprazole IM depot. Total = Participants with multiple ratings within the same category were counted towards the total (used in result table).
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End point type |
Primary
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End point timeframe |
At baseline and Phase C trial weeks 1 to 52/ET
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was specified for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Injection Site Evaluations (Pain, Redness, Swelling, Induration) by Investigator Rating [8] | ||||||||||||||||||||||
End point description |
Participants were followed for 1 hour post-injection and the investigator (or qualified designee) re-assessed localized pain, redness, swelling, and induration at the injection site at 1 hour (± 15 minutes) post-injection with focus on the most recent injection site. Injection evaluations were completed on the same day that the injection was administered. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale ranging from absent to severe. The participant indicated the degree of pain at the most recent injection site using a VAS. Ratings ranged from 0 (no pain) to 100 (unbearably painful).
Analysis Population Description:
All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase
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End point type |
Primary
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End point timeframe |
At baseline and Phase C trial weeks 4, 8, 12 to 48
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was specified for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Percentage of Participants Who Remained Stable at End of Treatment in Phase C | ||||||||||||||||||||||||||||||||||||||||
End point description |
To evaluate the efficacy, as measured by the percentage of stable partcipants at baseline who remained stable at the end of treatment in the IM depot maintenance phase C, of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to participants with bipolar I disorder.
Analysis Population Description
IM Depot Maintenance Phase Efficacy Sample: All participants who entered the IM Depot Maintenance Phase, received at least 1 dose of aripiprazole IM depot, and had at least 1 post-baseline efficacy evaluation in the IM Depot Maintenance Phase. Number analyzed (n) is the number of participants evaluated at the specified trial week.
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End point type |
Secondary
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End point timeframe |
At baseline, and phase C trial weeks 2, 4, 8, 12 to 52/ET
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Any adverse events (AEs) were recorded from the signing of informed consent onward.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Phase C: Open-label IM Depot Maintenance Phase
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Reporting group description |
All De novo participants received open-label aripiprazole 400/300 mg IM depot and the participants who completed Trial 31-08-250 entered phase C on aripiprazole IM depot 400 mg, regardless of their last dose of IM depot. De novo participants also received daily supplemental oral aripiprazole (10 to 20 mg daily for non-Japanese sites; 6 to 18 mg for Japanese sites) for the first 2 weeks to maintain therapeutic plasma concentrations. For participants who completed Trial 31-08-250 (some of whom had received double-blind placebo), the use of supplemental oral aripiprazole for the first ≤ 2 weeks was at the investigator's discretion based on the clinical status of the participant. Administration of rescue therapy was recommended for participants who did not meet stability criteria during the IM Depot Maintenance Phase, unless in the investigator’s judgment withdrawal from the trial was considered more appropriate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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29 Oct 2013 |
Amendment 1- Clarifications and additions to trial procedures and inclusion/exclusion criteria intended to enhance subject safety and accuracy of data. |
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04 Feb 2015 |
Amendment 2- Due to a well-established safety profile in the completed aripiprazole IM depot trials, as well as sufficient collection of safety data within this
trial, the duration of the IM Depot Maintenance Phase of the trial was reduced from 52 weeks to 28 weeks for rollover subjects (but not for de novo subjects or subjects at sites in Japan). The reduction of the IM Depot Maintenance Phase is described in detail in CSR Section 9.1.4 and in protocol Amendment 2 (Section 16.1.1, Appendix 23). |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
