Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia (ATTAIN 266)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01149655
First received: June 22, 2010
Last updated: April 1, 2015
Last verified: April 2015
Results First Received: November 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Aripiprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A Phase 3 randomized, double-blind, placebo-controlled study consisted of screening period, conversion (Period 1), stabilization (Period 2), double-blind maintenance treatment (Period 3) and a follow-up period to evaluate efficacy and safety of aripiprazole (10-30 mg/day) compared to placebo in adolescent participants with schizophrenia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were titrated to oral aripiprazole in Period 1. Participants who converted to aripiprazole and who already received aripiprazole were in Period 2. Participants met stability criteria were randomized in 2:1 ratio (aripiprazole: placebo) in Period 3. 244 participants were screened of which 201 entered the trial and 146 were randomized.

Reporting Groups
  Description
Aripiprazole-Conversion Phase Participants who had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
Aripiprazole-Stabilization Phase Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
Aripiprazole-Double Blind (DB) Maintenance Participants who met stability criteria in period 2 (stabilization phase) received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
Aripiprazole-Placebo-DB Maintenance Participants who met stability criteria in period 2 (stabilization phase) received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).

Participant Flow for 3 periods

Period 1:   Period 1 - Conversion Phase
    Aripiprazole-Conversion Phase     Aripiprazole-Stabilization Phase     Aripiprazole-Double Blind (DB) Maintenance     Aripiprazole-Placebo-DB Maintenance  
STARTED     186     0     0     0  
COMPLETED     168     0     0     0  
NOT COMPLETED     18     0     0     0  
Lost to Follow-up                 1                 0                 0                 0  
Sponsor Discontinued Trial                 4                 0                 0                 0  
Met Withdrawal Criteria                 1                 0                 0                 0  
Physician Decision                 2                 0                 0                 0  
Withdrawal by Subject                 7                 0                 0                 0  
Adverse Event Without Relapse                 3                 0                 0                 0  

Period 2:   Period 2-Stabilization Phase
    Aripiprazole-Conversion Phase     Aripiprazole-Stabilization Phase     Aripiprazole-Double Blind (DB) Maintenance     Aripiprazole-Placebo-DB Maintenance  
STARTED     0     183     0     0  
COMPLETED     0     146     0     0  
NOT COMPLETED     0     37     0     0  
Sponsor Discontinued Trial                 0                 16                 0                 0  
Met Withdrawal Criteria                 0                 7                 0                 0  
Physician Decision                 0                 3                 0                 0  
Withdrawal by Subject                 0                 5                 0                 0  
Adverse Event Without Relapse                 0                 6                 0                 0  

Period 3:   Period 3-DB Maintenance Phase
    Aripiprazole-Conversion Phase     Aripiprazole-Stabilization Phase     Aripiprazole-Double Blind (DB) Maintenance     Aripiprazole-Placebo-DB Maintenance  
STARTED     0     0     98     48  
COMPLETED     0     0     15     6  
NOT COMPLETED     0     0     83     42  
Sponsor Discontinued Trial                 0                 0                 58                 19  
Physician Decision                 0                 0                 1                 0  
Withdrawal by Subject                 0                 0                 4                 4  
Adverse Event Without Relapse                 0                 0                 1                 1  
Relapse With AE                 0                 0                 19                 18  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aripiprazole-Double Blind Maintenance Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
Placebo-Double Blind Maintenance Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
Total Total of all reporting groups

Baseline Measures
    Aripiprazole-Double Blind Maintenance     Placebo-Double Blind Maintenance     Total  
Number of Participants  
[units: participants]
  98     48     146  
Age  
[units: Years]
Mean (Standard Deviation)
     
Male     15.3  (1.3)     15.6  (1.1)     15.4  (1.2)  
Female     15.4  (1.1)     15.3  (1.0)     15.3  (1.1)  
Gender  
[units: participants]
     
Female     36     14     50  
Male     62     34     96  



  Outcome Measures
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1.  Primary:   Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]

2.  Secondary:   Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]

3.  Secondary:   Percentage of Responders in Each Treatment Group.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit ]

4.  Secondary:   Percentage of Participants Who Had Achieved Remission.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]

5.  Secondary:   Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit ]

6.  Other Pre-specified:   Mean Change From Baseline to Endpoint in PANSS Total Score.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]

7.  Other Pre-specified:   Mean Change From Baseline to Endpoint in CGI-S Score.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]

8.  Other Pre-specified:   Mean CGI-I Score at Endpoint.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]

9.  Other Pre-specified:   Mean Change From Baseline to Endpoint in PANSS Positive Subscale.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]

10.  Other Pre-specified:   Mean Change From Baseline to Endpoint in PANSS Negative Subscale.   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]

11.  Other Pre-specified:   Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).   [ Time Frame: Baseline to Week 52/End of Phase 3 visit. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
phone: 800 562-3974


No publications provided


Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01149655     History of Changes
Other Study ID Numbers: 31-09-266
Study First Received: June 22, 2010
Results First Received: November 26, 2014
Last Updated: April 1, 2015
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Romania: National Agency for Medicines and Medical Devices
India: Drugs Controller General of India
Taiwan : Food and Drug Administration
Philippines: Bureau of Food and Drugs
Malaysia: Institutional Review Board