A Phase 2 interventional study of ADT and OPC-34712 in Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 32 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-11-06.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 1,036 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
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Exclusion Criteria:
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment
Drug: ADT · Drug: OPC-34712
Once daily dosing during the duration of the study.
Also known as: Anti-depressant Drug Therapy
OPC-34712, Oral Tablets, 0.25 - 3 mg
Participants With Adverse Events (AEs).
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.
Time frame: After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 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, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.
Time frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.
Time frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)
1036 participants entered trial, including 792 who had rolled over from previous studies and 244 de novo participants. Of the 792 rollovers, 337 were 6-week enrollers and the 52-week enrollers consisted of 699 enrolled participants (455 rollover and 244 de novo). This was a single arm study and all participants received the same treatment.
| Milestone | Brexpiprazole +ADT |
|---|---|
| Started | 1036 |
| Completed | 560 |
| Not completed | 476 |
| Withdrew: Lost to follow-up | 52 |
| Withdrew: Adverse event | 127 |
| Withdrew: Participant met withdrawal criteria | 40 |
| Withdrew: Withdrawal by subject | 100 |
| Withdrew: Protocol deviation | 83 |
| Withdrew: Lack of efficacy | 68 |
| Withdrew: Physician decision | 6 |
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.
| Participants | Brexpiprazole+ADT |
|---|---|
| Participants with TEAEs | 851 |
| Participants with serious TEAEs | 30 |
The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 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, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.
| Units on a scale | Brexpiprazole+ADT |
|---|---|
| Week 1 | -0.09 ± 0.60 |
| Week 2 | -0.35 ± 0.82 |
| Week 4 | -0.63 ± 0.96 |
| Week 6 | -0.79 ± 1.03 |
| Week 8 | -0.92 ± 1.12 |
| Week 14 | -0.93 ± 1.14 |
| Week 20 | -1.08 ± 1.17 |
| Week 26 | -1.13 ± 1.24 |
| Week 32 | -1.24 ± 1.24 |
| Week 38 | -1.37 ± 1.28 |
| Week 44 | -1.46 ± 1.27 |
| Week 52 | -1.52 ± 1.34 |
| Week 52-LOCF | -0.81 ± 1.24 |
The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.
| Units on a scale | Brexpiprazole+ADT |
|---|---|
| Week 1 | 3.38 ± 0.94 |
| Week 2 | 3.04 ± 1.06 |
| Week 4 | 2.67 ± 1.09 |
| Week 6 | 2.46 ± 1.10 |
| Week 8 | 2.36 ± 1.10 |
| Week 14 | 2.36 ± 1.23 |
| Week 20 | 2.22 ± 1.17 |
| Week 26 | 2.16 ± 1.12 |
| Week 32 | 2.08 ± 1.13 |
| Week 38 | 1.97 ± 1.11 |
| Week 44 | 1.91 ± 1.14 |
| Week 52 | 1.92 ± 1.15 |
| Week 52-LOCF | 2.57 ± 1.31 |
Collected over After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brexpiprazole+ADT | — | 29/697 (4.2%) | 684/1,034 (66.2%) |
| Event | Brexpiprazole+ADT |
|---|---|
| DepressionPsychiatric disorders | 3/697 |
| Suicidal ideationPsychiatric disorders | 3/697 |
| Suicide attemptPsychiatric disorders | 3/697 |
| Intentional overdoseInjury, poisoning and procedural complications | 2/697 |
| AnxietyPsychiatric disorders | 2/697 |
| PancreatitisGastrointestinal disorders | 1/697 |
| Non-cardiac chest painGeneral disorders | 1/697 |
| CholecystitisHepatobiliary disorders | 1/697 |
| CholelithiasisHepatobiliary disorders | 1/697 |
| PneumoniaInfections and infestations | 1/697 |
| Event | Brexpiprazole+ADT |
|---|---|
| Weight increasedInvestigations | 217/1034 |
| AkathisiaNervous system disorders | 102/1034 |
| FatigueGeneral disorders | 95/1034 |
| SomnolenceNervous system disorders | 94/1034 |
| InsomniaPsychiatric disorders | 91/1034 |
| Increased appetiteMetabolism and nutrition disorders | 87/1034 |
| HeadacheNervous system disorders | 87/1034 |
| Upper respiratory tract infectionInfections and infestations | 67/1034 |
| AnxietyPsychiatric disorders | 67/1034 |
| DizzinessNervous system disorders | 60/1034 |
| Age, Continuous(Years) | Brexpiprazole+ADT |
|---|---|
| Mean | 44.0 ± 11.0 |
| Sex: Female, Male(Participants) | Brexpiprazole+ADT |
|---|---|
| Female | 702 |
| Male | 334 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical Development & Commercialization, Inc.