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

History of Changes

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

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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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

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1. Primary:

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

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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.

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

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