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

November 4, 2015 updated by: Cenk Tek, Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: week 10
change in body weight from baseline
week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lab values
Time Frame: week 10
change in fasting serum glucose, glycosylated hemoglobin, insulin, LDL cholesterol, triglyceride levels from baseline to week 10
week 10
Change in ratings of quality of life and cognition
Time Frame: week 10
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 16, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1103008158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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