ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial) (Orion)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01360866
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Interventions Drug: OPC-34712
Drug: Escitalopram
Drug: Fluoxetine
Drug: Paroxetine CR
Drug: Sertraline
Drug: Duloxetine
Drug: Venlafaxine XR
Enrollment 2944
Recruitment Details This trial was conducted in 2944 participants at 188 sites in 11 countries: Canada, France, Germany, Hungary, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, and United States (US).
Pre-assignment Details The study population consisted of eligible participants who completed one of the double-blind, phase 3 brexpiprazole major depressive disorder (MDD) trials and who, could potentially benefit from adjunctive treatment with oral brexpiprazole for MDD.
Arm/Group Title Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Hide Arm/Group Description Participants who received placebo with antidepressant therapy [ADT] in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received only ADT in previous double blind phase 3 studies and were not randomized, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Period Title: Overall Study
Started 516 707 1645 76
Completed 295 420 1126 54
Not Completed 221 287 519 22
Reason Not Completed
Lost to Follow-up             11             28             41             0
Adverse Event             56             61             134             6
Paticipant met withdrawal criteria             11             28             54             0
Withdrawn by Investigator             9             8             31             2
Withdrawal by participant             79             89             168             8
Protocol Deviation             25             33             61             2
Lack of Efficacy             30             40             30             4
Arm/Group Title Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel Total
Hide Arm/Group Description Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Total of all reporting groups
Overall Number of Baseline Participants 516 707 1645 76 2944
Hide Baseline Analysis Population Description
comprised of all participants who signed an informed consent form (ICF) for the trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 516 participants 707 participants 1645 participants 76 participants 2944 participants
45.0  (11.0) 45.0  (11.0) 44.0  (12.0) 44.0  (11.0) 45.0  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 516 participants 707 participants 1645 participants 76 participants 2944 participants
Female
367
  71.1%
479
  67.8%
1108
  67.4%
51
  67.1%
2005
  68.1%
Male
149
  28.9%
228
  32.2%
537
  32.6%
25
  32.9%
939
  31.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 516 participants 707 participants 1645 participants 76 participants 2944 participants
White
452
  87.6%
609
  86.1%
1459
  88.7%
68
  89.5%
2588
  87.9%
Black or African American
55
  10.7%
76
  10.7%
149
   9.1%
8
  10.5%
288
   9.8%
American Indian or Alaska Native
0
   0.0%
6
   0.8%
8
   0.5%
0
   0.0%
14
   0.5%
Asian
5
   1.0%
8
   1.1%
8
   0.5%
0
   0.0%
21
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
6
   0.4%
0
   0.0%
6
   0.2%
Other
4
   0.8%
8
   1.1%
15
   0.9%
0
   0.0%
27
   0.9%
1.Primary Outcome
Title Adverse Events (AEs) - All Participants
Hide Description To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.
Time Frame From screening to week 52/early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs.
Arm/Group Title Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Hide Arm/Group Description:
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Overall Number of Participants Analyzed 516 706 1640 76
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with adverse events
400
  77.5%
511
  72.4%
1165
  71.0%
51
  67.1%
Participants with treatment emergent AE (TEAE)
399
  77.3%
510
  72.2%
1163
  70.9%
51
  67.1%
Participants with serious TEAE
14
   2.7%
23
   3.3%
33
   2.0%
1
   1.3%
Participants with severe TEAE
48
   9.3%
64
   9.1%
99
   6.0%
4
   5.3%
Partcipants discontinued due to AEs
55
  10.7%
58
   8.2%
134
   8.2%
6
   7.9%
2.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
Hide Description The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: “Considering your total clinical experience with this particular population, how mentally ill was the participant at that 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.
Time Frame From screening to week 52/early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.
Arm/Group Title Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Hide Arm/Group Description:
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Overall Number of Participants Analyzed 512 698 1630 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.77  (1.11) -0.63  (1.16) -0.48  (1.04) -0.93  (0.85)
3.Secondary Outcome
Title Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
Hide Description The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant’s condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.
Time Frame From screening to week 52/early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.
Arm/Group Title Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Hide Arm/Group Description:
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Overall Number of Participants Analyzed 505 693 1606 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.60  (1.30) 2.63  (1.34) 2.63  (1.39) 2.40  (1.17)
4.Secondary Outcome
Title Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
Hide Description

The SDS was a self-rated instrument used to measure the effect of the participant’s symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely.

Scores of 5 and above were associated with significant functional impairment.

Time Frame From screening to week 52/early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.
Arm/Group Title Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Hide Arm/Group Description:
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Overall Number of Participants Analyzed 346 457 1165 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.80  (2.80) -0.70  (2.60) -0.40  (2.30) -1.00  (1.70)
5.Secondary Outcome
Title Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score
Hide Description

The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the “best” rating and 3 being the “worst” rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst).

Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.

Time Frame From screening to week 52/early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.
Arm/Group Title Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Hide Arm/Group Description:
Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
Overall Number of Participants Analyzed 491 664 1556 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.25  (12.21) -4.76  (11.79) -3.94  (10.57) -7.44  (8.89)
Time Frame From screening to 30 (+ 2) days following the 52 weeks treatment period or early termination.
Adverse Event Reporting Description

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related.

An AE was considered serious if it resulted in any of the following outcomes: fatal; life threatening; persistently or significantly disabling or incapacitating; required inpatient hospitalization or prolonged existing hospitalization; a congenital anomaly/birth defect; or other medically significant event

 
Arm/Group Title Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Hide Arm/Group Description Participants who received placebo with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received Brexpiprazole with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received only ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment. Participants who received Seroquel with ADT in previous double blind phase 3 studies, received 0.5 to 3 mg/day Brexpiprazole + ADT for weeks 1, 2, 4, 8,14, 20, 26, 32, 38, 44 and 52 with dose adjustment.
All-Cause Mortality
Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/516 (0.39%)   2/706 (0.28%)   0/1640 (0.00%)   0/76 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/516 (2.71%)   23/706 (3.26%)   33/1640 (2.01%)   1/76 (1.32%) 
Blood and lymphatic system disorders         
Iron Deficiency Anaemia * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Cardiac disorders         
Aortic Valve Incompetence * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Cardiac Failure Congestive * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Ventricular Dysfunction * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Eye disorders         
Blepharospasm * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Retinal Vein Thrombosis * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Crohn's Disease * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Gastric Ulcer Perforation * 1  1/516 (0.19%)  0/706 (0.00%)  0/1640 (0.00%)  0/76 (0.00%) 
General disorders         
Chest Pain * 1  0/516 (0.00%)  0/706 (0.00%)  2/1640 (0.12%)  0/76 (0.00%) 
Drug Withdrawal Syndrome * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis * 1  0/516 (0.00%)  0/706 (0.00%)  2/1640 (0.12%)  0/76 (0.00%) 
Hepatitis Acute * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Infections and infestations         
Bronchitis * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Cellulitis * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Diverticulitis * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Gastroenteritis * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Herpes Zoster * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Kidney Infection * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Peritonitis * 1  1/516 (0.19%)  0/706 (0.00%)  0/1640 (0.00%)  0/76 (0.00%) 
Pneumonia * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Upper Respiratory Tract Infection * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Fall * 1  1/516 (0.19%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Intentional Overdose * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Patella Fracture * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Investigations         
Electrocardiogram Qt Prolonged * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Metabolism and nutrition disorders         
Type 2 Diabetes Mellitus * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Musculoskeletal and connective tissue disorders         
Intervertebral Disc Protrusion * 1  1/516 (0.19%)  0/706 (0.00%)  0/1640 (0.00%)  0/76 (0.00%) 
Lumbar Spinal Stenosis * 1  0/516 (0.00%)  0/706 (0.00%)  0/1640 (0.00%)  1/76 (1.32%) 
Spinal Osteoarthritis * 1  1/516 (0.19%)  0/706 (0.00%)  0/1640 (0.00%)  0/76 (0.00%) 
Spondylolisthesis * 1  0/516 (0.00%)  0/706 (0.00%)  0/1640 (0.00%)  1/76 (1.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast Cancer * 1  0/516 (0.00%)  1/706 (0.14%)  1/1640 (0.06%)  0/76 (0.00%) 
Intraductal Proliferative Breast Lesion * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Ovarian Cancer * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Pancreatic Neuroendocrine Tumour * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Rectal Adenocarcinoma * 1  1/516 (0.19%)  0/706 (0.00%)  0/1640 (0.00%)  0/76 (0.00%) 
Renal Cell Carcinoma * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Nervous system disorders         
Cerebrovascular Accident * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Dizziness * 1  0/516 (0.00%)  0/706 (0.00%)  2/1640 (0.12%)  0/76 (0.00%) 
Dyskinesia * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Extrapyramidal Disorder * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Lumbar Radiculopathy * 1  1/516 (0.19%)  0/706 (0.00%)  0/1640 (0.00%)  0/76 (0.00%) 
Ruptured Cerebral Aneurysm * 1  1/516 (0.19%)  0/706 (0.00%)  0/1640 (0.00%)  0/76 (0.00%) 
Sciatica * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Syncope * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Psychiatric disorders         
Completed Suicide * 1  0/516 (0.00%)  2/706 (0.28%)  0/1640 (0.00%)  0/76 (0.00%) 
Depression * 1  2/516 (0.39%)  3/706 (0.42%)  3/1640 (0.18%)  0/76 (0.00%) 
Depressive Symptom * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Intentional Self-Injury * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Major Depression * 1  1/516 (0.19%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Mania * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Suicidal Ideation * 1  0/516 (0.00%)  1/706 (0.14%)  1/1640 (0.06%)  0/76 (0.00%) 
Suicide Attempt * 1  2/516 (0.39%)  1/706 (0.14%)  1/1640 (0.06%)  0/76 (0.00%) 
Renal and urinary disorders         
Renal Disorder * 1  0/516 (0.00%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
Reproductive system and breast disorders         
Pelvic Adhesions * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  1/516 (0.19%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Chronic Obstructive Pulmonary * 1  0/516 (0.00%)  0/706 (0.00%)  1/1640 (0.06%)  0/76 (0.00%) 
Pulmonary Embolism * 1  2/516 (0.39%)  1/706 (0.14%)  0/1640 (0.00%)  0/76 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prior Placebo Prior Brexpiprazole Prior ADT Prior Seroquel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   296/516 (57.36%)   323/706 (45.75%)   787/1640 (47.99%)   33/76 (43.42%) 
Gastrointestinal disorders         
Constipation * 1  14/516 (2.71%)  15/706 (2.12%)  33/1640 (2.01%)  4/76 (5.26%) 
Nausea * 1  26/516 (5.04%)  32/706 (4.53%)  61/1640 (3.72%)  4/76 (5.26%) 
General disorders         
Fatigue * 1 [1]  37/516 (7.17%)  50/706 (7.08%)  88/1640 (5.37%)  3/76 (3.95%) 
Infections and infestations         
Viral Upper Respiratory Tract Infection * 1  25/516 (4.84%)  35/706 (4.96%)  98/1640 (5.98%)  2/76 (2.63%) 
Investigations         
Weight Increased * 1  118/516 (22.87%)  100/706 (14.16%)  296/1640 (18.05%)  5/76 (6.58%) 
Metabolism and nutrition disorders         
Increased Appetite * 1  37/516 (7.17%)  28/706 (3.97%)  117/1640 (7.13%)  3/76 (3.95%) 
Nervous system disorders         
Akathisia * 1  54/516 (10.47%)  37/706 (5.24%)  99/1640 (6.04%)  7/76 (9.21%) 
Headache * 1  42/516 (8.14%)  55/706 (7.79%)  105/1640 (6.40%)  9/76 (11.84%) 
Somnolence * 1  40/516 (7.75%)  60/706 (8.50%)  130/1640 (7.93%)  5/76 (6.58%) 
Psychiatric disorders         
Anxiety * 1  39/516 (7.56%)  37/706 (5.24%)  76/1640 (4.63%)  0/76 (0.00%) 
Insomnia * 1  30/516 (5.81%)  40/706 (5.67%)  108/1640 (6.59%)  6/76 (7.89%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
[1]
General Disorders and Administration Site Conditions
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Until the information herein is released by Otsuka to the public domain, the contents of this document are Otsuka confidential information and should not be duplicated or re-distributed without prior written consent of Otsuka.
Results Point of Contact
Name/Title: Global Clinical Development
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 609 524 6788
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01360866     History of Changes
Other Study ID Numbers: 331-10-238
First Submitted: May 24, 2011
First Posted: May 26, 2011
Results First Submitted: May 25, 2018
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018