An Open-Label Pilot Trial of Alpha Lipoic Acid (ALA) for Weight Loss in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cenk Tek, Yale University
ClinicalTrials.gov Identifier:
NCT01355952
First received: May 16, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Obesity
Weight Loss
Schizophrenia
Dietary Supplement: Alpha Lipoic Acid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: week 10 ] [ Designated as safety issue: No ]
    change in body weight from baseline


Secondary Outcome Measures:
  • 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).


Enrollment: 17
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355952

Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Cenk Tek, M.D. Yale University
  More Information

No publications provided

Responsible Party: Cenk Tek, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01355952     History of Changes
Other Study ID Numbers: 1103008158
Study First Received: May 16, 2011
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Obesity
Weight Loss
Schizophrenia
Alpha Lipoic Acid

Additional relevant MeSH terms:
Obesity
Schizophrenia
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 28, 2014