Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2017-06-30

Brief Summary

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Anorexia Nervosa (AN) is a serious illness associated with substantial morbidity and mortality. Weight restoration is a treatment priority, and better treatments are needed.

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Detailed Description

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Control group receiving placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Control Group will receive placebo pill

Olanzapine

Group receiving olanzapine

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Placebo

Control Group will receive placebo pill

Intervention Type DRUG

Other Intervention Names

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Zyprexa

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Anorexia Nervosa
* Body Mass Index (BMI) between 14.0 and 18.5 kg/m2
* Between 18-75 years old
* Patient not pursuing intensive treatment (inpatient or day treatment) for weight restoration if BMI less than 18 kg/m2
* serum potassium \> 2.5 mEq/L

Exclusion Criteria

* Any medical or psychiatric problem requiring medical or psychiatric attention, significant metabolic disturbance upon psychiatrist presentation, and/or significant co-morbid illnesses that are not likely to benefit from proposed treatments or that need specialized treatments for non-eating disorder symptoms.
* Diabetes mellitus
* QTc \> 480 msec at baseline or increase in QTc of \> 35 msec since baseline ECG
* Significant hyperlipidemia (cholesterol, triglycerides \> 1.5 x upper limit of normal)
* Current diagnosis of substance abuse or dependence
* Diagnosis of schizophrenia, schizophreniform disorder, bipolar illness (type I)
* Presence of movement disorder, tardive dyskinesia
* History of seizure disorder
* Dementia (subjects over age 55 will be assessed by an MMSE administered by a psychiatrist; those who receive an MMSE score \>25 will be excluded)
* Allergy to olanzapine
* Documented treatment with 10 mg/day olanzapine x 8 weeks or known inability to tolerate olanzapine 10 mg/day
* Taking psychotropic (antidepressant, antianxiety, mood stabilizer, antipsychotic) medication within the 4 weeks prior to randomization, other than stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin/Norepinephrine Reuptake Inhibitor (SNRI), or use of benzodiazepine or non-benzodiazepine sleep agents. These permissible medications may be continued during the trial if they have been in use by the patient for a period of \> 4 weeks at an unchanged dose without any evidence of consistent weight gain (i.e., \> 3 lbs/months)
* Taking other medication within the last four weeks prior to randomization, known to affect weight (e.g., steroids)
* Participation in a psychotherapeutic intervention associated with consistent weight gain (i.e. \> 3 lbs/month). (Subjects may participate in the study if they are receiving stable outpatient psychotherapy for the 4 weeks prior to randomization as long as there have been no changes in therapy intensity and the psychotherapy has not been associated with weight gain \> 3 lbs over the previous 4 weeks. Subjects may also participate if they recently received partial weight restoration treatment in an intensive inpatient or day program as long as they can document that they have not consistently gained weight in their current treatment setting for the 4 weeks prior to baseline screening.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No