Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa
Anorexia Nervosa (AN) is a serious illness associated with substantial morbidity and mortality. Weight restoration is a treatment priority, and better treatments are needed.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Olanzapine vs Placebo for Outpatients With Anorexia Nervosa|
- Rate of Weight Gain [ Time Frame: Weekly during 16-week trial and twice during 8 weeks follow-up ] [ Designated as safety issue: No ]Comparison of rate of weight gain between patients receiving olanzapine and those receiving placebo
- Psychological Improvement [ Time Frame: Weekly during 16-week intervention and twice during 8-week follow-up ] [ Designated as safety issue: No ]Comparison of psychological improvement, specifically obsessionality as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Control group receiving placebo
Control Group will receive placebo pill
Group receiving olanzapine
Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.
Other Name: Zyprexa
This study is a 16-week randomized, double-blind, placebo-controlled trial of olanzapine in adult outpatients with AN. 160 individuals with AN, ages > 18, will be randomly assigned to receive olanzapine or placebo for 16 weeks together with a medication management treatment. Primary outcomes will include weight gain as well as psychological symptoms known to be associated with AN, including obsessionality, mood, and anxiety.
This project is based on evidence from a recently completed 8-week pilot study comparing the efficacy of olanzapine to placebo in outpatients with AN (PI: Evelyn Attia, MD), as well as a recently published 12-week trial of olanzapine vs placebo (Bissada et al, Am J Psychiatry, 2007) in which outpatient treatment with olanzapine was associated with weight improvement, improved psychological status, and no untoward metabolic effects among low-weight patients.
The investigators hypothesize that among underweight adult outpatients with AN receiving olanzapine vs. placebo, together with medication management treatment: 1)patients with AN receiving olanzapine will gain weight at a faster rate than those receiving placebo; and 2) patients with AN receiving olanzapine will demonstrate greater reduction in psychological symptoms, including obsessionality, mood, anxiety and eating disorder symptoms, than those receiving placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170117
|Contact: Meg Martinez, BSfirstname.lastname@example.org|
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|Contact: Angela Guarda, MD 410-955-3863 email@example.com|
|Principal Investigator: Angela Guarda, MD|
|United States, New York|
|New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Evelyn Attia, MD 212-543-5923 firstname.lastname@example.org|
|Principal Investigator: Evelyn Attia, MD|
|Weill Cornell Medical Center||Recruiting|
|White Plains, New York, United States, 10605|
|Contact: Evelyn Attia, MD 914-997-8677 email@example.com|
|Principal Investigator: Evelyn Attia, MD|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Marsha Marcus, PhD 412-246-6371 firstname.lastname@example.org|
|Principal Investigator: Marsha Marcus, PhD|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M5T1R8|
|Contact: Allan Kaplan, MD 416.535.8501 ext 4980 Allan_kaplan@camh.net|
|Principal Investigator: Allan Kaplan, MD|
|Principal Investigator:||Evelyn Attia, MD||New York State Psychiatric Institute|