Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

NCT00793780 | Completed Results

• 1 other identifier: 0808004106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to find out how effective low dose oral naltrexone is on reducing body weight when compared to placebo in women with schizophrenia and schizoaffective disorder.

Conditions

Obesity; Schizophrenia; Schizoaffective Disorder

Keywords

obesity; schizophrenia; schizoaffective disorder; weight loss

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight From Baseline

  Weight was measured with shoes off to the nearest 0.1 kg.

  8 weeks

Secondary Outcomes (5)

• Fasting Serum Glucose Lab Values

  baseline and 8 weeks

• PANSS- Positive and Negative Symptom Scale

  8 weeks

• Insulin Levels

  baseline and week 8

• LDL Cholesterol

  baseline and week 8

• Change in Questionnaire on Craving for Sweet or Rich Foods Score

  baseline and week 8

Study Arms (2)

Naltrexone 25mg

ACTIVE COMPARATOR

Drug: Naltrexone 25mg

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Naltrexone 25mg DRUG

Naltrexone 25mg caplets taken orally once a day for 8 weeks

Naltrexone 25mg

Placebo OTHER

Placebo caplet (inactive substance) taken orally once a day for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between the ages of 18 to 70
• Meet DSM-IV (Diagnostic and Statistical Manual version IV) criteria for schizophrenia or schizoaffective disorder based on SCID (Structured Clinical Interview for the DSM-IV) interview
• Overweight, as defined with a BMI of equal to or greater than 27 kg/m² and continuing weight gain in the past year above 2% of previous years total body weight
• 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

You may not qualify if:

• Meet criteria for current alcohol or other substance dependence, opioid use for any reason or positive urine drug screen for opiates
• 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
• Known sensitivity to naltrexone
• A medical disorder that is known to cause obesity
• Use of sibutramine, topiramate, amphetamines or over the counter weight remedies
• Impaired liver functions (greater than 3 times the upper limit of normal)
• Diagnosed with polycystic ovary syndrome
• Currently being treated with insulin
• Current use of Depo-Provera or any natural/synthetic hormone treatment known to cause significant weight gain

Sponsors & Collaborators

• Yale University: lead
• Ethel F. Donaghue Women's Health Investigator Program at Yale: collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

• Tek C, Ratliff J, Reutenauer E, Ganguli R, O'Malley SS. A randomized, double-blind, placebo-controlled pilot study of naltrexone to counteract antipsychotic-associated weight gain: proof of concept. J Clin Psychopharmacol. 2014 Oct;34(5):608-12. doi: 10.1097/JCP.0000000000000192.

  PMID: 25102328 RESULT

MeSH Terms

Conditions

Obesity; Schizophrenia; Psychotic Disorders; Weight Loss

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Body Weight Changes

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Erin Sullivan
• Organization: Yale University

erin.reutenauer@yale.edu

+1 (203) 974-7317

Study Officials

• Cenk Tek, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 6, 2016
• Results First Posted: October 6, 2016

Record last verified: 2016-08

Locations

US (1)