Trial Outcomes & Findings for Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia (NCT NCT00794963)

NCT ID: NCT00794963

Last Updated: 2015-04-15

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: baseline and 8 months
• Results posted on: 2015-04-15

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	4	4
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	1	4

Baseline Characteristics

Aggressive Treatment of Metabolic Syndrome in Patients Receiving Clozapine for Schizophrenia

Baseline characteristics by cohort

Measure	Integrated Care n=4 Participants Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic	Usual Care n=4 Participants Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53.7 years STANDARD_DEVIATION 4.8 • n=5 Participants	43.5 years STANDARD_DEVIATION 5.6 • n=7 Participants	48.6 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 months

Population: 4 participants in usual care arm did not return for follow-up and were not available for analysis; 1 participant in the integrated care group was lost to follow-up

Outcome measures

Measure	Integrated Care n=3 Participants 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
Change in Weight	11 pounds Standard Deviation 5.6	—

Adverse Events

Integrated Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Manu, MD

North Shore Long Island Jewish Health System, Zucker Hillside Hospita, Glen Oaks, NY

Phone: 718 470-8290 pmanu@nshs.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place