An Open-Label Pilot Trial of Alpha Lipoic Acid (ALA) for Weight Loss in Schizophrenia
Condition: Obesity; Weight Loss; Schizophrenia
MeSH terms: Body Weight; Weight Loss; Schizophrenia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Alpha Lipoic Acid
Intervention type(s): Dietary Supplement
Intervention description(s): 600mg three times per day (1800mg total) daily for 10 weeks
Intervention MeSH terms: Thioctic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight Loss; Schizophrenia; Alpha Lipoic Acid