Trial · NCT01360632
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
NCT01360632, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2016-01-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial). Trials, record NCT01360632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01360632
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
- NCT number
- NCT01360632
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,539 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
- Interventions
- OPC-34712 + ADT, Placebo + ADT, Placebo + ADT
- First posted
- 2011-05-25
- Last updated
- 2016-01-01
- Results first posted
- 2016-01-01
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set | Baseline and Week 14 | The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome. |
| Primary | Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol | Baseline and Week 14 | The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome. |
| Secondary | Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set | Week 8, 9, 10, 11, 12, and 13 | The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome. |
| Secondary | Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol | Week 8, 9, 10, 11, 12, and 13 | The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome. |
| Secondary | Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set | Week 11 and Week 14 | The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable. |
| Secondary | Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol | Week 11 and Week 14 | The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable. |
| Secondary | Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set | Week 11 and Week 14 | The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable. |
| Secondary | Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol | Week 11 and Week 14 | The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable. |
| Secondary | Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set | Weeks 8, 9, 10, 11, 12,13 and 14 | The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. |
| Secondary | Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol | Weeks 8, 9, 10, 11, 12, 13, and 14 | The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set | Baseline and Week 14 | The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol | Baseline and Week 14 | Analysis was based on all participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set | Week 8, 9, 10, 11, 12, and 13 | The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol | Week 8, 9, 10, 11, 12, and 13 | All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set | Week 11 and Week 14 | The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol | Week 11 and Week 14 | All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set | Week 11 and Week 14 | The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol | Week 11 and Week 14 | All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set | Weeks 8, 9, 10, 11, 12,13 and 14 | The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol | Weeks 8, 9, 10, 11, 12, 13, and 14 | All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group312
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set | Brexpiprazole (1mg) + ADT | -7.65 | Standard Error 0.5 | Units on a scale | |
| Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set | Brexpiprazole (3mg) + ADT | -7.98 | Standard Error 0.51 | Units on a scale | |
| Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set | Placebo + ADT | -6.45 | Standard Error 0.51 | Units on a scale | |
| Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol | Brexpiprazole (1mg) + ADT | -7.64 | Standard Error 0.52 | Units on a scale | |
| Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol | Brexpiprazole (3mg) + ADT | -8.29 | Standard Error 0.53 | Units on a scale | |
| Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol | Placebo + ADT | 6.33 | Standard Error 0.53 | Units on a scale | |
| Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set | Brexpiprazole (1mg) + ADT | Week 9 | -3.25 | Standard Error 0.3 | Units on a scale |
| Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set | Brexpiprazole (3mg) + ADT | Week 9 | -2.53 | Standard Error 0.3 | Units on a scale |
| Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set | Placebo + ADT | Week 9 | -2.19 | Standard Error 0.31 | Units on a scale |
| Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set | Brexpiprazole (1mg) + ADT | Week 10 | -5.34 | Standard Error 0.38 | Units on a scale |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase A (8 Weeks) | STARTED | Single-blind Placebo + ADT | 1,532 | |
| Phase A (8 Weeks) | STARTED | Brexpiprazole (1mg) + ADT | 0 | |
| Phase A (8 Weeks) | STARTED | Brexpiprazole (3mg) + ADT | 0 | |
| Phase A (8 Weeks) | STARTED | Double-blind Placebo + ADT | 0 | |
| Phase A (8 Weeks) | STARTED | Phase A+ Placebo + ADT | 0 | |
| Phase A (8 Weeks) | COMPLETED | Single-blind Placebo + ADT | 1,277 | |
| Phase A (8 Weeks) | COMPLETED | Brexpiprazole (1mg) + ADT | 0 | |
| Phase A (8 Weeks) | COMPLETED | Brexpiprazole (3mg) + ADT | 0 | |
| Phase A (8 Weeks) | COMPLETED | Double-blind Placebo + ADT | 0 | |
| Phase A (8 Weeks) | COMPLETED | Phase A+ Placebo + ADT | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events24
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 | Nasopharyngitis | Infections and infestations | Brexpiprazole (1mg + ADT) | 15 | 226 | |
| other | Nasopharyngitis | Infections and infestations | Brexpiprazole (3mg + ADT) | 7 | 229 | |
| other | Nasopharyngitis | Infections and infestations | Placebo + ADT | 4 | 220 | |
| other | Weight increased | Investigations | Brexpiprazole (1mg + ADT) | 15 | 226 | |
| other | Weight increased | Investigations | Brexpiprazole (3mg + ADT) | 13 | 229 | |
| other | Weight increased | Investigations | Placebo + ADT | 2 | 220 | |
| other | Akathisia | Nervous system disorders | Brexpiprazole (1mg + ADT) | 10 | 226 | |
| other | Akathisia | Nervous system disorders | Brexpiprazole (3mg + ADT) | 31 | 229 | |
| other | Akathisia | Nervous system disorders | Placebo + ADT | 5 | 220 | |
| other | Headache | Nervous system disorders | Brexpiprazole (1mg + ADT) | 21 | 226 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brexpiprazole (1mg + ADT) | ||
| Total, all-cause mortality | Brexpiprazole (3mg + ADT) | ||
| Total, all-cause mortality | Placebo + ADT | ||
| Total, other adverse events | Brexpiprazole (1mg + ADT) | 63 | 226 |
| Total, other adverse events | Brexpiprazole (3mg + ADT) | 72 | 229 |
| Total, other adverse events | Placebo + ADT | 29 | 220 |
| Total, serious adverse events | Brexpiprazole (1mg + ADT) | 1 | 226 |
| Total, serious adverse events | Brexpiprazole (3mg + ADT) | 1 | 229 |
| Total, serious adverse events | Placebo + ADT | 0 | 220 |
Source ClinicalTrials.gov
Papers10
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/NCT01360632
GET https://conductscience.org/api/trials/v1/NCT01360632/registered?page=2