Trial · NCT02600494
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
NCT02600494, Phase 3, Completed, Intra-Cellular Therapies, Inc.; results first posted 2025-11-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression. Trials, record NCT02600494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02600494
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
- NCT number
- NCT02600494
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 554 participants, actual
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Conditions
- Bipolar Depression
- Interventions
- ITI-007 (Lumateperone), Placebo
- First posted
- 2015-11-09
- Last updated
- 2025-11-03
- Results first posted
- 2025-11-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | 6 weeks | 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 | Time to First Sustained Response in Reduction of MADRS Total Score | 6 weeks | |
| Other | Change From Baseline to Day 175 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 175 | The MADRS total score from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B) |
| Other | Adverse Events | Day 175 | Incidence of Treatment-Emergent Adverse Events from baseline to Day 175 for patients that rolled over into the extension portion of the study (Part B) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | 6 weeks | Intent-to-Treat (ITT) Set contains all randomized patients who received at least one dose of study medication and who 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 | Time to First Sustained Response in Reduction of MADRS Total Score | 6 weeks | days | MEDIAN | |
| OTHER_PRE_SPECIFIED | Change From Baseline to Day 175 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Day 175 | Safety Analysis Set - all patients who received at least 1 dose of study medication in Part B | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Adverse Events | Day 175 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | -18.9 | Standard Error 1.11 | score on a scale | |
| Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | -20.7 | Standard Error 1.16 | score on a scale | |
| Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Placebo | -19.7 | Standard Error 1.11 | score on a scale | |
| Time to First Sustained Response in Reduction of MADRS Total Score | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 43 | 95% Confidence Interval 36 to NA | days | |
| Time to First Sustained Response in Reduction of MADRS Total Score | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 38 | 95% Confidence Interval 36 to NA | days | |
| Time to First Sustained Response in Reduction of MADRS Total Score | Placebo | 37 | 95% Confidence Interval 30 to NA | days | |
| Change From Baseline to Day 175 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | -8.9 | Standard Deviation 10.76 | units on a scale | |
| Adverse Events | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Headache | 26 | Participants | |
| Adverse Events | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Dry Mouth | 15 | Participants | |
| Adverse Events | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | Dizziness | 13 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (6 Week Double-Blind Treatment) | STARTED | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 183 | |
| Part A (6 Week Double-Blind Treatment) | STARTED | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 185 | |
| Part A (6 Week Double-Blind Treatment) | STARTED | Placebo | 186 | |
| Part A (6 Week Double-Blind Treatment) | Number of Patients Randomized and Took at Least 1 Dose of Study Drug | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 180 | |
| Part A (6 Week Double-Blind Treatment) | Number of Patients Randomized and Took at Least 1 Dose of Study Drug | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 184 | |
| Part A (6 Week Double-Blind Treatment) | Number of Patients Randomized and Took at Least 1 Dose of Study Drug | Placebo | 185 | |
| Part A (6 Week Double-Blind Treatment) | COMPLETED | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 126 | |
| Part A (6 Week Double-Blind Treatment) | COMPLETED | Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 113 | |
| Part A (6 Week Double-Blind Treatment) | COMPLETED | Placebo | 138 | |
| Part A (6 Week Double-Blind Treatment) | NOT COMPLETED | Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 57 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events80
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 | Somnolence | Nervous system disorders | Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 21 | 180 | |
| other | Somnolence | Nervous system disorders | Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 24 | 184 | |
| other | Somnolence | Nervous system disorders | Part A Placebo | 7 | 185 | |
| other | Somnolence | Nervous system disorders | Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 11 | 127 | |
| other | Headache | Nervous system disorders | Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 35 | 180 | |
| other | Headache | Nervous system disorders | Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 20 | 184 | |
| other | Headache | Nervous system disorders | Part A Placebo | 10 | 185 | |
| other | Headache | Nervous system disorders | Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 26 | 127 | |
| other | Nausea | Gastrointestinal disorders | Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 12 | 180 | |
| other | Nausea | Gastrointestinal disorders | Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 16 | 184 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 0 | 180 |
| Total, all-cause mortality | Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 0 | 184 |
| Total, all-cause mortality | Part A Placebo | 1 | 185 |
| Total, all-cause mortality | Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 0 | 127 |
| Total, other adverse events | Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 72 | 180 |
| Total, other adverse events | Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 67 | 184 |
| Total, other adverse events | Part A Placebo | 31 | 185 |
| Total, other adverse events | Part B Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 55 | 127 |
| Total, serious adverse events | Part A Lumateperone 28 mg (ITI-007 40 mg Tosylate) | 5 | 180 |
| Total, serious adverse events | Part A Lumateperone 42 mg (ITI-007 60 mg Tosylate) | 0 | 184 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41017591 | DERIVED |
Source PubMed
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/NCT02600494
GET https://conductscience.org/api/trials/v1/NCT02600494/flow?page=2