Effectiveness of Olanzapine Versus Placebo in Treating Outpatients With Anorexia Nervosa
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Atypical Antipsychotic Medication in Anorexia Nervosa|
- Weight Gain [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
- Anxiety [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Participants will take olanzapine.
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.
Other Name: zyprexa
Placebo Comparator: 2
Participants will take matched placebo.
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.
Anorexia nervosa (AN) is a disease of disordered eating and is characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. Symptoms and behaviors of AN may include distorted body image, obsessive exercise, lack of menstruation among women, binge and purge eating behaviors, and intense fear of weight gain. Furthermore, people with AN are at a high risk of other mental disorders, such as depression and anxiety, and medical complications, such as organ damage, heart failure, and osteoporosis. Current treatments for AN include nutrition counseling, psychotherapy, and medication. Although weight restoration is a treatment priority, no particular therapeutic approach for patients with AN has clear empirical support. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in increasing appetite and reducing anxiety related to weight gain and eating in people with AN. Specifically, the atypical antipsychotic medication olanzapine may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of the antipsychotic medication olanzapine versus placebo in treating outpatients with AN.
Participation in this study will last 8 weeks. All participants will first undergo baseline assessments that will include questionnaires and interviews about AN symptoms, a physical exam, vital sign measurements, an electrocardiograph (EKG), and a blood draw. Participants will then be assigned randomly to 8 weeks of daily treatment with olanzapine or placebo. Participants will meet with a study doctor weekly over the 8 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. Participants will also fill out weekly questionnaires about the status of their condition and monthly repeat baseline questionnaires. In addition, participants will undergo blood draws every 2 weeks for the first month of the study and every 4 weeks for the remainder of the study. Upon completing the 8 weeks of treatment, participants will repeat the baseline assessments. During the next 5 years, participants may be contacted to complete a follow-up interview.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692185
|United States, New York|
|Eating Disorders Clinic, New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Evelyn Attia, MD||New York State Psychiatric Institute at Columbia University Medical Center|