Trial · NCT02600507
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
NCT02600507, Phase 3, Completed, Intra-Cellular Therapies, Inc.; results first posted 2023-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression. Trials, record NCT02600507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02600507
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
- NCT number
- NCT02600507
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 529 participants, actual
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Conditions
- Bipolar Depression
- Interventions
- Lumateperone (ITI-007), Placebo
- First posted
- 2015-11-09
- Last updated
- 2023-05-17
- Results first posted
- 2023-05-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Baseline to Day 43 | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms. |
| Secondary | Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score | Baseline to Day 43 | The Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score is a clinician-rated scale that measures the patient's current state of depression from 1 (not ill at all) to 7 (among the most extremely ill). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Baseline to Day 43 | Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score | Baseline to Day 43 | Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and had a valid baseline (pre-dose) measurement and at least one valid post-baseline measurement of MADRS total score. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | -16.2 | Standard Error 0.79 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | -16.9 | Standard Error 0.81 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Placebo | -14.5 | Standard Error 0.79 | score on a scale | |
| Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | -1.7 | Standard Error 0.09 | score on a scale | |
| Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | -1.8 | Standard Error 0.10 | score on a scale | |
| Change From Baseline in Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) Depression Score | Placebo | -1.5 | Standard Error 0.09 | score on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 176 | |
| Overall Study | STARTED | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 177 | |
| Overall Study | STARTED | Placebo | 175 | |
| Overall Study | COMPLETED | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 147 | |
| Overall Study | COMPLETED | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 133 | |
| Overall Study | COMPLETED | Placebo | 150 | |
| Overall Study | NOT COMPLETED | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 29 | |
| Overall Study | NOT COMPLETED | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 44 | |
| Overall Study | NOT COMPLETED | Placebo | 25 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 23 | 176 | |
| other | Headache | Nervous system disorders | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 20 | 177 | |
| other | Headache | Nervous system disorders | Placebo | 20 | 175 | |
| other | Somnolence | Nervous system disorders | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 13 | 176 | |
| other | Somnolence | Nervous system disorders | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 20 | 177 | |
| other | Somnolence | Nervous system disorders | Placebo | 6 | 175 | |
| other | Dizziness | Nervous system disorders | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 18 | 176 | |
| other | Dizziness | Nervous system disorders | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 19 | 177 | |
| other | Dizziness | Nervous system disorders | Placebo | 4 | 175 | |
| other | Nausea | Gastrointestinal disorders | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 10 | 176 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 0 | 176 |
| Total, all-cause mortality | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 0 | 177 |
| Total, all-cause mortality | Placebo | 0 | 175 |
| Total, other adverse events | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 50 | 176 |
| Total, other adverse events | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 47 | 177 |
| Total, other adverse events | Placebo | 28 | 175 |
| Total, serious adverse events | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 0 | 176 |
| Total, serious adverse events | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 1 | 177 |
| Total, serious adverse events | Placebo | 0 | 175 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02600507
GET https://conductscience.org/api/trials/v1/NCT02600507/registered