Overview

This trial is active, not recruiting.

Condition anorexia nervosa
Treatments olanzapine, placebo
Sponsor New York State Psychiatric Institute
Collaborator National Institute of Mental Health (NIMH)
Start date August 2010
End date June 2016
Trial size 152 participants
Trial identifier NCT01170117, #6142/7117R, R01MH085921

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Control group receiving placebo
placebo
Control Group will receive placebo pill
(Experimental)
Group receiving olanzapine
olanzapine Zyprexa
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.

Primary Outcomes

Measure
Rate of Weight Gain
time frame: Weekly during 16-week trial and twice during 8 weeks follow-up
Psychological Improvement
time frame: Weekly during 16-week intervention and twice during 8-week follow-up

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.)

Additional Information

Official title Olanzapine vs Placebo for Outpatients With Anorexia Nervosa
Principal investigator Evelyn Attia, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.