Trial record 1 of 1 for:    comparison of optimal antipsychotic treatments for adults with schizophrenia
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Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia (COATS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00802100
First received: December 3, 2008
Last updated: January 3, 2013
Last verified: April 2012
Results First Received: November 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Olanzapine
Drug: Perphenazine
Drug: Aripiprazole
Drug: Metformin
Drug: Simvastatin
Drug: Benztropine

  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
This feasibility-focused pilot study was conducted at 14 clinical sites affiliated with the Schizophrenia Trials Network in 2008-9.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Olanzapine

Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.

Olanzapine dose 10-30 mg/day Metformin dose 850-2550 mg/day

Perphenazine

Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.

Perphenazine dose 8-24 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day

Aripiprazole

Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.

Aripiprazole dose 10-30 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day


Participant Flow:   Overall Study
    Olanzapine     Perphenazine     Aripiprazole  
STARTED     6     9     6  
COMPLETED     0     2     2  
NOT COMPLETED     6     7     4  



  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
Olanzapine Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
Perphenazine Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
Aripiprazole Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
Total Total of all reporting groups

Baseline Measures
    Olanzapine     Perphenazine     Aripiprazole     Total  
Number of Participants  
[units: participants]
  6     9     6     21  
Age  
[units: years]
Mean ± Standard Deviation
  30  ± 9.7     30  ± 8.1     27  ± 7.9     29  ± 8.2  
Gender  
[units: participants]
       
Female     2     4     2     8  
Male     4     5     4     13  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study   [ Time Frame: Baseline ]

2.  Secondary:   Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment   [ Time Frame: Measured over 28 weeks of study visits ]


  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
It was determined in this pilot study that the existing procedures and eligibility criteria could not be adequately implemented and that a larger-scale study was not feasible.


  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: Scott Stroup
Organization: Columbia University
phone: (212) 543-5676
e-mail: stroups@nyspi.columbia.edu


No publications provided


Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00802100     History of Changes
Other Study ID Numbers: N01 MH090001-02, N01MH90001
Study First Received: December 3, 2008
Results First Received: November 19, 2012
Last Updated: January 3, 2013
Health Authority: United States: Federal Government