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Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01447576
Recruitment Status : Completed
First Posted : October 6, 2011
Results First Posted : November 6, 2015
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: ADT
Drug: OPC-34712
Enrollment 1036
Recruitment Details 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.
Pre-assignment Details Eligible participants received daily treatment with open-label brexpiprazole (0.25 up to 3.0 milligrams (mg)/day) and commercially marketed ADT.
Arm/Group Title Brexpiprazole +ADT
Hide Arm/Group Description All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
Period Title: Overall Study
Started 1036
Completed 560
Not Completed 476
Reason Not Completed
Lost to Follow-up             52
Adverse Event             127
Participant met withdrawal criteria             40
Withdrawal by Subject             100
Protocol deviation             83
Lack of Efficacy             68
Physician Decision             6
Arm/Group Title Brexpiprazole+ADT
Hide Arm/Group Description All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
Overall Number of Baseline Participants 1036
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1036 participants
44.0  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1036 participants
Female
702
  67.8%
Male
334
  32.2%
1.Primary Outcome
Title Participants With Adverse Events (AEs).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The primary safety dataset included all participants exposed to at least 1 dose of brexpiprazole.
Arm/Group Title Brexpiprazole+ADT
Hide Arm/Group Description:
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
Overall Number of Participants Analyzed 1034
Measure Type: Number
Unit of Measure: Participants
Participants with TEAEs 851
Participants with serious TEAEs 30
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Hide Description 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])
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and at least 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.
Arm/Group Title Brexpiprazole+ADT
Hide Arm/Group Description:
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
Overall Number of Participants Analyzed 1032
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
3.Secondary Outcome
Title Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and atleast 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.
Arm/Group Title Brexpiprazole+ADT
Hide Arm/Group Description:
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
Overall Number of Participants Analyzed 1023
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
Time Frame 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.
Adverse Event Reporting Description The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
 
Arm/Group Title Brexpiprazole+ADT
Hide Arm/Group Description Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT.
All-Cause Mortality
Brexpiprazole+ADT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole+ADT
Affected / at Risk (%)
Total   29/697 (4.16%) 
Gastrointestinal disorders   
Pancreatitis * 1  1/697 (0.14%) 
General disorders   
Non-cardiac chest pain * 1  1/697 (0.14%) 
Hepatobiliary disorders   
Cholecystitis * 1  1/697 (0.14%) 
Cholelithiasis * 1  1/697 (0.14%) 
Infections and infestations   
Pneumonia * 1  1/697 (0.14%) 
Pyelonephritis * 1  1/697 (0.14%) 
Injury, poisoning and procedural complications   
Intentional overdose * 1  2/697 (0.29%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/697 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma of the cervix * 1  1/697 (0.14%) 
Metastatic malignant melanoma * 1  1/697 (0.14%) 
Nervous system disorders   
Convulsion * 1  1/697 (0.14%) 
Cranial nerve paralysis * 1  1/697 (0.14%) 
Dizziness * 1  1/697 (0.14%) 
Sciatica * 1  1/697 (0.14%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/697 (0.14%) 
Psychiatric disorders   
Anxiety * 1  2/697 (0.29%) 
Depression * 1  3/697 (0.43%) 
Depression suicidal * 1  1/697 (0.14%) 
Depressive symptom * 1  1/697 (0.14%) 
Suicidal ideation * 1  3/697 (0.43%) 
Suicide attempt * 1  3/697 (0.43%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/697 (0.14%) 
Pneumothorax * 1  1/697 (0.14%) 
Pulmonary embolism * 1  1/697 (0.14%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Brexpiprazole+ADT
Affected / at Risk (%)
Total   684/1034 (66.15%) 
Gastrointestinal disorders   
Constipation * 1  41/1034 (3.97%) 
Diarrhoea * 1  42/1034 (4.06%) 
Dry mouth * 1  40/1034 (3.87%) 
Nausea * 1  50/1034 (4.84%) 
General disorders   
Fatigue * 1  95/1034 (9.19%) 
Infections and infestations   
Upper respiratory tract infection * 1  67/1034 (6.48%) 
Nasopharyngitis * 1  47/1034 (4.55%) 
Investigations   
Weight increased * 1  217/1034 (20.99%) 
Metabolism and nutrition disorders   
Increased appetite * 1  87/1034 (8.41%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  33/1034 (3.19%) 
Nervous system disorders   
Akathisia * 1  102/1034 (9.86%) 
Dizziness * 1  60/1034 (5.80%) 
Headache * 1  87/1034 (8.41%) 
Sedation * 1  54/1034 (5.22%) 
Somnolence * 1  94/1034 (9.09%) 
Tremor * 1  42/1034 (4.06%) 
Psychiatric disorders   
Anxiety * 1  67/1034 (6.48%) 
Insomnia * 1  91/1034 (8.80%) 
Restlessness * 1  59/1034 (5.71%) 
Abnormal dreams * 1  41/1034 (3.97%) 
Middle insomnia * 1  24/1034 (2.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01447576     History of Changes
Other Study ID Numbers: 331-08-212
First Submitted: September 29, 2011
First Posted: October 6, 2011
Results First Submitted: August 4, 2015
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015