Clinical Trial Results:
An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder
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Summary
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EudraCT number |
2021-001172-41 |
Trial protocol |
CZ SK HU BG PL SE FI |
Global end of trial date |
23 Oct 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Nov 2025
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First version publication date |
14 Nov 2025
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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 |
ITI-007-503
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05061719 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Intra-Cellular Therapies, Inc.
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Sponsor organisation address |
135 Route 202/206, Suite 6, Bedminster, NJ, United States, 07921
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Public contact |
ITI Clinical Trials, Intra-Cellular Therapies, Inc., +1 646-440-9333, ITCIClinicalTrials@itci-inc.com
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Scientific contact |
ITI Clinical Trials, Intra-Cellular Therapies, Inc., +1 646-440-9333, ITCIClinicalTrials@itci-inc.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 |
09 Dec 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Oct 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Oct 2024
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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 |
To evaluate the safety and tolerability of lumateperone 42 mg administered orally once daily for approximately 26 weeks as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD).
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Protection of trial subjects |
The study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki. The study complied with the ICH Guidance on General Considerations for Clinical Trials and GCP, as well as CFR Part 312.
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Background therapy |
Subjects continued to take one of the following antidepressants as monotherapy treatment that they had taken in the Lead-In Study: a. citalopram/escitalopram b. fluoxetine c. paroxetine d. sertraline e. duloxetine f. levomilnacipran/milnacipran (if locally approved for MDD) g. venlafaxine/desvenlafaxine h. bupropion i. vilazodone j. vortioxetine | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Sep 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
India: 53
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Country: Number of subjects enrolled |
Poland: 147
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Country: Number of subjects enrolled |
Slovakia: 32
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Country: Number of subjects enrolled |
Sweden: 2
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Country: Number of subjects enrolled |
Bulgaria: 159
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Country: Number of subjects enrolled |
Czechia: 95
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Country: Number of subjects enrolled |
Germany: 25
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Country: Number of subjects enrolled |
Hungary: 15
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Country: Number of subjects enrolled |
United States: 225
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Country: Number of subjects enrolled |
Argentina: 56
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Worldwide total number of subjects |
809
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EEA total number of subjects |
475
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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) |
796
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From 65 to 84 years |
13
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
The Screening phase began once the Informed Consent Form was signed. Subjects enrolled in this open-label safety study had to have completed 1 of 2 double-blind lead-in studies. | ||||||||||||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
812 [1] | ||||||||||||||||||||||||
Number of subjects completed |
809 | ||||||||||||||||||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Consent withdrawn by subject: 2 | ||||||||||||||||||||||||
Reason: Number of subjects |
Lost to follow-up: 1 | ||||||||||||||||||||||||
| Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Pre-assignment period includes all subjects that are screened. Worldwide number enrolled are those subjects that have been enrolled. |
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Period 1
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Period 1 title |
Overall Trial (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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Lumateperone 42 mg + ADT | ||||||||||||||||||||||||
Arm description |
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Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Lumateperone
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Investigational medicinal product code |
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Other name |
ITI-007
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Lumateperone 42 mg once daily oral administration
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Baseline characteristics reporting groups
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Reporting group title |
Lumateperone 42 mg + ADT
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Lumateperone 42 mg + ADT
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Reporting group description |
- | ||
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End point title |
The Number and Percentage of Subjects Reporting Treatment Emergent Adverse Events [1] | ||||||||
End point description |
548 out of 809 subjects (67.74%) reported at least 1 TEAE
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End point type |
Primary
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End point timeframe |
26 weeks
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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: As this was an open-label safety study there was no comparison to placebo or other treatment. The Primary outcome was number and percentage of of subjects that reported a TEAE. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in one of the 6 Week Double-blind Lead-in Studies to the End of the Open-Label Treatment Period in the Montgomery-Åsberg Depression Rating Scale | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up to 32 weeks
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in one of the 6 Week Double-blind Lead-in Studies to the End of the Open-Label Treatment Period in the Clinical Global Impression Scale-Severity | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up to 32 weeks
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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 |
From signing ICF until end of study procedures (~28 weeks), including 26 weeks of open-label treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.0
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Reporting groups
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Reporting group title |
Lumateperone 42 mg + ADT
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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23 Aug 2021 |
Verified Clinical Trials (VCT) was used to monitor for patient participation in other clinical trials; Added Study Stopping Criteria and clarified study discontinuation and patient-level stopping criteria; Clarified the definition of TEAEs to be reported during the OLTP; Updated study drug supply and storage information. |
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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 | |||
