Status:
COMPLETED
Metabolic Effects of Melatonin in Patients Treated With Second Generation Antipsychotics
Lead Sponsor:
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Conditions:
Second Generation Antipsychotic Induced Metabolic Adverse Effects
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
Schizophrenia and bipolar disorder are frequently associated with an elevated risk for obesity, metabolic syndrome, diabetes mellitus, dyslipidemia and other metabolic disturbances. Second Generation ...
Eligibility Criteria
Inclusion
- Men and non-pregnant, non-lactating women aged between 18 and 45 years;
- DSM-IV-TR criteria for schizophrenia or bipolar disorder type I;
- free of concomitant medical or neurological illness (as per review of systems and general physical examination);
- free of DSM-IV current substance abuse or a history of substance dependence in the last six months;
- who were initiated on continuous treatment with SGA (clozapine, olanzapine, quetiapine or risperidone) for a period no greater than the last three months prior to their inclusion to the present study.
Exclusion
- were diagnosed with hypertension, diabetes mellitus, dyslipidemia, thyroid disorders or hepatic illness;
- had a history of hypersensitivity to melatonin;
- exhibited high risk for suicide or high risk for aggressiveness;
- women who were not practicing reliable forms of contraception. Patients were eliminated from the study if they suspended SGA or two consecutive doses of the study capsule at any point during the follow up period.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01811160
Start Date
October 1 2008
End Date
November 1 2011
Last Update
March 14 2013
Active Locations (1)
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1
Instituto Nacional de Psiquiatría "Dr. Ramón de la Fuente"
Mexico City, México City, Mexico, 14370