An Open-Label Pilot Trial of Alpha Lipoic Acid (ALA) for Weight Loss in Schizophrenia
ALA
1 other identifier
interventional
17
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 5, 2015
November 1, 2015
1.6 years
May 16, 2011
November 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Body Weight
change in body weight from baseline
week 10
Secondary Outcomes (2)
Change in lab values
week 10
Change in ratings of quality of life and cognition
week 10
Study Arms (1)
Alpha Lipoic Acid
EXPERIMENTALtaking 1800mg daily (600mg 3 times per day) Alpha Lipoic Acid (ALA) open-label for 10 weeks.
Interventions
600mg three times per day (1800mg total) daily for 10 weeks
Eligibility Criteria
You may qualify if:
- Age 18 to 70 years;
- Meet DSM-IV criteria for schizophrenia or schizoaffective disorder (confirmed from clinical chart)
- Overweight, as defined with a BMI of equal to or greater than 27 kg/m²;
- 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;
- Deemed to be symptomatically stable by the clinical staff in the last two months;
- \) English speaking
You may not qualify if:
- A history of dementia, mental retardation or other neurological disorder that may interfere with study ratings;
- Not capable of giving informed consent for participation in this study;
- Ongoing pregnancy;
- A medical disorder that is known to cause obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Connecticut Mental Health Center
New Haven, Connecticut, 06519, United States
Related Publications (1)
Ratliff JC, Palmese LB, Reutenauer EL, Tek C. An open-label pilot trial of alpha-lipoic acid for weight loss in patients with schizophrenia without diabetes. Clin Schizophr Relat Psychoses. 2015 Jan;8(4):196-200.
PMID: 23471087DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cenk Tek, M.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 19, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 5, 2015
Record last verified: 2015-11