Effectiveness of Olanzapine Versus Placebo in Treating Outpatients With Anorexia Nervosa

Eating Disorders Clinical Trial

Official title:

Atypical Antipsychotic Medication in Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692185
• Other study ID #: #5116 (MH069868-02)
• Secondary ID: 1R21MH069868-01D
• Status: Completed
• Phase: Phase 2
• Start date: October 2005
• Est. completion date: September 2010

Study information

• Verified date: April 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Meets DSM-IV criteria (not including amenorrhea) for AN

• Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2

• Patient (or family if the patient is a minor) refuses hospitalization

• Free of psychotropic medication (4 weeks medication free for fluoxetine and antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry

• Prior treatment of AN

Exclusion Criteria:

• Any medical or psychiatric problem requiring urgent attention and/or any significant comorbid illness not likely to benefit from proposed treatments

• Allergy to olanzapine

• Significant orthostatic high blood pressure

• Recent commencement of psychotherapy in the community

• Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose greater than 140 mg/dL

• Known history of current or past jaundice

• Known history of narrow angle glaucoma

• Active substance abuse or dependence

• Schizophrenia, schizophreniform disorder, or bipolar illness

• Movement disorder or presence of tics

• History of tardive dyskinesia

• History of seizures

• Pregnant

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Drug:
• Olanzapine
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.
• Placebo
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.

Locations

Country	Name	City	State
United States	Eating Disorders Clinic, New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain		Measured at Week 8
Secondary	Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale	The Yale Brown Cornell-Eating Disorders Scale was used.This scale assesses severity of preoccupations and rituals. There are 8 questions that can be scored between 0-4 to indicate severity of symptoms, with 0 representing less severe and 4 representing most severe symptoms. The scores were summed, with possible results totaling 0-32.	Measured at Week 8