Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa
|ClinicalTrials.gov Identifier: NCT01170117|
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Drug: Olanzapine Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Olanzapine vs Placebo for Outpatients With Anorexia Nervosa|
|Actual Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2017|
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
- Rate of Weight Change [ Time Frame: Weekly during 16-week trial and twice during 8 weeks follow-up ]Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo
- Psychological Change [ Time Frame: Weekly during 16-week intervention and twice during 8-week follow-up ]Comparison of psychological change as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo. The Y-BOCS is divided into two sections: obsessive and compulsive. The scores for each section range from 1 to 20. The overall scores are obtained from adding scores for the two sections, to obtain a range between 2-40. A lower score reflects improvement/ fewer obsessive compulsive symptoms. A score of 25 or more is considered moderately severe, a score of 30 or more is considered severe, and a score of more than 35 is considered very severe.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170117
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Weill Cornell Medical Center|
|White Plains, New York, United States, 10605|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T1R8|
|Principal Investigator:||Evelyn Attia, MD||New York State Psychiatric Institute|