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Trial record 1 of 1 for:    NCT01810783
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Brexpiprazole in Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01810783
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : February 23, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Brexpiprazole
Enrollment 210
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Period Title: Overall Study
Started 210
Completed 101
Not Completed 109
Reason Not Completed
Adverse Event             32
Withdrawal by Subject             22
Lack of Efficacy             12
Lost to Follow-up             10
Protocol Violation             5
Non-compliance with IMP             4
Adminstrative or other reason(s)             23
Enrolled, not treated             1
Arm/Group Title Brexpiprazole
Hide Arm/Group Description Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Overall Number of Baseline Participants 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants
<=18 years
1
   0.5%
Between 18 and 65 years
208
  99.0%
>=65 years
1
   0.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 210 participants
40.89  (11.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants
Female
113
  53.8%
Male
97
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 210 participants
United States 50
Ukraine 64
Slovakia 1
Serbia 19
Russian Federation 52
Estonia 6
Poland 9
Romania 9
1.Primary Outcome
Title Safety and Tolerability
Hide Description Number of treatment-emergent adverse events (TEAEs)
Time Frame Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)
Hide Outcome Measure Data
Hide Analysis Population Description
210 patients were enrolled, only 209 patients were treated with brexpiprazole.TAES is based on these 209 patients
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:
Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Overall Number of Participants Analyzed 209
Measure Type: Number
Unit of Measure: TEAEs
337
Time Frame Baseline to end of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brexpiprazole
Hide Arm/Group Description 210 were enrolled, only 209 patients were treated with brexpiprazole
All-Cause Mortality
Brexpiprazole
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Brexpiprazole
Affected / at Risk (%)
Total   31/209 (14.83%) 
Gastrointestinal disorders   
Colitis  1  1/209 (0.48%) 
Infections and infestations   
Peritonsillar abscess  1  1/209 (0.48%) 
Injury, poisoning and procedural complications   
Humerus fracture  1  1/209 (0.48%) 
Investigations   
Alanine aminotransferase increased  1  1/209 (0.48%) 
Aspartate aminotransferase increased  1  1/209 (0.48%) 
Blood bilirubin increased  1  1/209 (0.48%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung carcinoma cell type unspecified stage iv  1  1/209 (0.48%) 
Nervous system disorders   
Grand mal convulsion  1  1/209 (0.48%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy  1 [1]  1/112 (0.89%) 
Psychiatric disorders   
Aggression  1  1/209 (0.48%) 
Panic attack  1  1/209 (0.48%) 
Psychotic disorder  1  2/209 (0.96%) 
Schizophrenia  1  18/209 (8.61%) 
Suicidal ideation  1  2/209 (0.96%) 
Suicide attempt  1  1/209 (0.48%) 
Renal and urinary disorders   
Urinary retention  1  1/209 (0.48%) 
Social circumstances   
Social stay hospitalisation  1  2/209 (0.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
[1]
210 were enrolled, only 209 patients were treated with brexpiprazole, where 112 were women
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brexpiprazole
Affected / at Risk (%)
Total   47/209 (22.49%) 
Investigations   
Weight increased  1  22/209 (10.53%) 
Nervous system disorders   
Headache  1  18/209 (8.61%) 
Psychiatric disorders   
Insomnia  1  17/209 (8.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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: Email contact via
Organization: H. Lundbeck A/S
EMail: LundbeckClinicalTrials@Lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01810783    
Other Study ID Numbers: 14644B
2012-002705-21 ( EudraCT Number )
First Submitted: March 12, 2013
First Posted: March 14, 2013
Results First Submitted: December 30, 2016
Results First Posted: February 23, 2017
Last Update Posted: March 27, 2017