Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia - Study Results

Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia (ATOMICS)

This study has been terminated.

( Difficulty recruiting )

Study NCT00794963 Information provided by North Shore Long Island Jewish Health System

First Received on November 19, 2008. Last Updated on November 17, 2011 History of Changes

Results First Received: July 19, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Metabolic Syndrome
Interventions:	Drug: Pravastatin, Fenofibrate, Metformin, Orlistat, irbesartan Other: As selected by community physician

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Integrated Care	Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
Usual Care	Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community

Participant Flow: Overall Study

	Integrated Care	Usual Care
STARTED	4	4
COMPLETED	3	0
NOT COMPLETED	1	4
Withdrawal by Subject	1	4

Baseline Characteristics

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Reporting Groups

	Description
Integrated Care	Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
Usual Care	Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community

Baseline Measures

	Integrated Care	Usual Care	Total
Number of Participants [units: participants]	4	4	8
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	4	4	8
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	53.7 ± 4.8	43.5 ± 5.6	48.6 ± 4.9
Gender [units: participants]
Female	1	0	1
Male	3	4	7
Region of Enrollment [units: participants]
United States	4	4	8

Outcome Measures

1. Primary:

Change in Weight [ Time Frame: baseline and 8 months ]

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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
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Results Point of Contact:

Name/Title: Peter Manu, MD
Organization: North Shore Long Island Jewish Health System, Zucker Hillside Hospita, Glen Oaks, NY
phone: 718 470-8290 pmanu@nshs.edu

No publications provided

Responsible Party:	Peter Manu, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00794963 History of Changes
Other Study ID Numbers:	08-177
Study First Received:	November 19, 2008
Results First Received:	July 19, 2011
Last Updated:	November 17, 2011
Health Authority:	United States: Institutional Review Board