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Melatonin for Olanzapine-Associated Metabolic Side Effects
NCT01593774Phase 2
Key facts
- Status
- Completed
- Start
- May 2012
- Primary completion
- Mar 2013
- Countries
- 1
- Sponsor
- Guilan University of Medical Sciences
- Modality
- Small Molecules
- Drugs
- melatonin
- Conditions
- hyperlipidemiahyperglycemia
01
Overview
Phase 2, randomised, double-blind trial of melatonin in hyperlipidemia and hyperglycemia, sponsored by Guilan University of Medical Sciences. Primary endpoint: Change from baseline in weight at 8 weeks. Started May 2012; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults (18-65) with first-episode schizophrenia starting olanzapine, excluding those with pre-existing metabolic issues, recent olanzapine use, or significant comorbidities.
04
Endpoints
Primary
Change from baseline in weight
Secondary
Change from baseline in Triglyceride
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