Obesity Clinical Trial
— ALAOfficial title:
An Open-Label Pilot Trial of Alpha Lipoic Acid (ALA) for Weight Loss in Schizophrenia
Verified date | November 2015 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The aim of this study is to collect pilot data to compare the effectiveness of treatment with Alpha Lipoic Acid (ALA) for reduction in body weight in 40 obese outpatients with schizophrenia or schizoaffective disorder in an open-label pilot trial. The investigators also plan to test the feasibility of utilizing ALA as a weight loss agent for obese outpatients with schizophrenia or schizoaffective disorder in terms of tolerability, schizophrenia symptoms, cognition and side effects. We have run a total of 12 non-diabetic participants and are now recruiting diabetic patients in hopes of comparing the two groups.
Status | Completed |
Enrollment | 17 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 to 70 years; 2. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder (confirmed from clinical chart) 3. Overweight, as defined with a BMI of equal to or greater than 27 kg/m²; 4. Be on a stable dose of antipsychotic medication; i.e. at least one month with no dosage change, and two months from an antipsychotic switch; 5. Deemed to be symptomatically stable by the clinical staff in the last two months; 8) English speaking Exclusion Criteria: 1. A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings; 2. Not capable of giving informed consent for participation in this study; 3. Ongoing pregnancy; 4. A medical disorder that is known to cause obesity |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Connecticut Mental Health Center | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Weight | change in body weight from baseline | week 10 | No |
Secondary | Change in lab values | change in fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels from baseline to week 10 | week 10 | Yes |
Secondary | Change in ratings of quality of life and cognition | 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). | week 10 | No |
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