Trial · NCT03249376
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
NCT03249376, Phase 3, Completed, Intra-Cellular Therapies, Inc.; results first posted 2022-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally. Trials, record NCT03249376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03249376
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
- NCT number
- NCT03249376
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 381 participants, actual
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Conditions
- Bipolar Depression
- Interventions
- Lumateperone, Placebo
- First posted
- 2017-08-15
- Last updated
- 2022-06-03
- Results first posted
- 2022-06-03
Source ClinicalTrials.gov
Registered outcomes3
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 (CGI-BP-S) Total Score | Baseline to Day 43 | The Clinical Global Impression Scale, Bipolar version (CGI-BP-S) total score is a clinician-rated scale that measures the patient's current illness state on a 3 to 21 point scale where a higher score is associated with greater illness severity.. Each domain (depression, mania, and overall illness) is rated from 1 (not ill at all) to 7 (among the most extremely ill) and the 3 scores are added to obtain the total score. |
| Secondary | Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score | Baseline to Day 43 | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 14 item patient self-reported questionnaire that assesses how satisfied a patient is, using a 5-point scale from 1-very poor to 5-very good. |
Source ClinicalTrials.gov
Outcomes3
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 (CGI-BP-S) 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 Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent 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. | Percent Score | 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 | -16.70 | Standard Error 0.693 | score on a scale | |
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Placebo | -12.12 | Standard Error 0.677 | score on a scale | |
| Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score | Lumateperone | -3.48 | Standard Error 0.170 | score on a scale | |
| Change From Baseline in Clinical Global Impression Scale, Bipolar Version (CGI-BP-S) Total Score | Placebo | -2.54 | Standard Error 0.167 | score on a scale | |
| Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score | Lumateperone | 19.4 | Standard Error 1.49 | Percent Score | |
| Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Percent Score | Placebo | 14.9 | Standard Error 1.45 | Percent Score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lumateperone | 188 | |
| Overall Study | STARTED | Placebo | 189 | |
| Overall Study | COMPLETED | Lumateperone | 167 | |
| Overall Study | COMPLETED | Placebo | 166 | |
| Overall Study | NOT COMPLETED | Lumateperone | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 23 |
Source ClinicalTrials.gov
Adverse events10
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 | 33 | 188 | |
| other | Headache | Nervous system disorders | Placebo | 19 | 189 | |
| other | Somnolence | Nervous system disorders | Lumateperone | 16 | 188 | |
| other | Somnolence | Nervous system disorders | Placebo | 2 | 189 | |
| other | Nauseau | Gastrointestinal disorders | Lumateperone | 12 | 188 | |
| other | Nauseau | Gastrointestinal disorders | Placebo | 4 | 189 | |
| other | Dizziness | Nervous system disorders | Lumateperone | 9 | 188 | |
| other | Dizziness | Nervous system disorders | Placebo | 10 | 189 | |
| serious | Mania | Psychiatric disorders | Lumateperone | 1 | 188 | 1 |
| serious | Mania | Psychiatric disorders | Placebo | 0 | 189 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lumateperone | 0 | 188 |
| Total, all-cause mortality | Placebo | 0 | 189 |
| Total, other adverse events | Lumateperone | 58 | 188 |
| Total, other adverse events | Placebo | 31 | 189 |
| Total, serious adverse events | Lumateperone | 1 | 188 |
| Total, serious adverse events | Placebo | 0 | 189 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lumateperone vs Placebo: deaths from any cause | Trial comparisons |
| Lumateperone vs Placebo: serious adverse events | Trial comparisons |
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/NCT03249376
GET https://conductscience.org/api/trials/v1/NCT03249376/registered