An Open-Label Pilot Trial of Alpha Lipoic Acid (ALA) for Weight Loss in Schizophrenia (ALA)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Pilot Trial of Alpha Lipoic Acid (ALA) for Weight Loss in Schizophrenia|
- Change in Body Weight [ Time Frame: week 10 ] [ Designated as safety issue: No ]change in body weight from baseline
- Change in lab values [ Time Frame: week 10 ] [ Designated as safety issue: Yes ]change in fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels from baseline to week 10
- Change in ratings of quality of life and cognition [ Time Frame: week 10 ] [ Designated as safety issue: No ]change in quality of life (Q-LES-Q), Clinical Global Impression (CGI) scores and performance on the The Brief Assessment of Cognition in Schizophrenia neurocognitive battery (BACS).
|Study Start Date:||May 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Alpha Lipoic Acid
taking 1800mg daily (600mg 3 times per day) Alpha Lipoic Acid (ALA) open-label for 10 weeks.
Dietary Supplement: Alpha Lipoic Acid
600mg three times per day (1800mg total) daily for 10 weeks
Design: This is a ten week open-label, fixed dose clinical study of alpha lipoic acid (ALA) for the treatment of antipsychotic weight gain in outpatients with schizophrenia or schizoaffective disorder.
Study Endpoints: The primary outcome measure is change in body weight from baseline. Secondary outcome measures are fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels, quality of life (Q-LES-Q), Clinical Global Impression (CGI) scores and performance on the The Brief Assessment of Cognition in Schizophrenia neurocognitive battery (BACS). (after preliminary analysis, we have changed the cognitive assessment to the DSST task only. The investigators are also going to conduct exploratory analyses of food craving, food preference and food frequency.
Subjects: Subjects will be recruited from the Psychosis Program and clinician referrals from other teams at the CMHC. Based on our previous weight loss studies the investigators expect very high enthusiasm from the subjects.
Procedure and assessment schedule: Subjects who meet the inclusion/exclusion criteria will participate in a multi-step screening process where demographic information will be gathered, weight and BMI will be measured and fasting blood will be taken, and if you are a female, a urine sample will be tested for pregnancy. If lab results are adequate, the subject will continue on to a baseline visit where they will start taking alpha lipoic acid (ALA) at 600mg three times a day (1800mg total) for a total of ten weeks. At each visit, weight will be obtained, scheduled blood will be drawn and study ratings will be conducted. A short visit with the physician every two weeks ensures safety and improves rating fidelity. Medication compliance will be ensured with pill counts, feedback and encouragement that is standard for clinical trials with schizophrenia patients. Research scales are standard schizophrenia and food scales.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355952
|United States, Connecticut|
|Connecticut Mental Health Center|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Cenk Tek, M.D.||Yale University|