Effectiveness of Olanzapine Versus Placebo in Treating Outpatients With Anorexia Nervosa

NCT ID: NCT00692185

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2010-09-30

Brief Summary

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

Detailed 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.

Conditions

Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Participants will take olanzapine.

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.

2

Participants will take matched placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.

Interventions

Olanzapine

Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.

Intervention Type: DRUG

Placebo

Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

zyprexa

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Evelyn Attia

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evelyn Attia, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute at Columbia University Medical Center

Locations

Eating Disorders Clinic, New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

Attia E, Kaplan AS, Walsh BT, Gershkovich M, Yilmaz Z, Musante D, Wang Y. Olanzapine versus placebo for out-patients with anorexia nervosa. Psychol Med. 2011 Oct;41(10):2177-82. doi: 10.1017/S0033291711000390. Epub 2011 Mar 22.

Reference Type: DERIVED

PMID: 21426603 (View on PubMed)

Other Identifiers

1R21MH069868-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR A2-AID

Identifier Type: -

Identifier Source: secondary_id

#5116 (MH069868-02)

Identifier Type: -

Identifier Source: org_study_id