Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

This study is currently recruiting participants.
Verified July 2013 by New York State Psychiatric Institute
Sponsor:
Collaborators:
Weill Medical College of Cornell University
University of Pittsburgh
Johns Hopkins University
University of Toronto
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01170117
First received: July 23, 2010
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Anorexia Nervosa
Drug: Olanzapine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Olanzapine vs Placebo for Outpatients With Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Rate of Weight Gain [ Time Frame: Weekly during 16-week trial and twice during 8 weeks follow-up ] [ Designated as safety issue: No ]
    Comparison of rate of weight gain between patients receiving olanzapine and those receiving placebo

  • Psychological Improvement [ Time Frame: Weekly during 16-week intervention and twice during 8-week follow-up ] [ Designated as safety issue: No ]
    Comparison of psychological improvement, specifically obsessionality as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo.


Estimated Enrollment: 160
Study Start Date: August 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Control group receiving placebo
Drug: Placebo
Control Group will receive placebo pill
Experimental: Olanzapine
Group receiving olanzapine
Drug: 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.
Other Name: Zyprexa

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Anorexia Nervosa
  • Body Mass Index (BMI) between 14.0 and 18.5 kg/m2
  • Between 18-55 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
  • 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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170117

Contacts
Contact: Meg Martinez, BS 212.543.5739 edru@pi.cpmc.columbia.edu

Locations
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Angela Guarda, MD    410-955-3863    aguarda@jhmi.edu   
Principal Investigator: Angela Guarda, MD         
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Evelyn Attia, MD    212-543-5923    ea12@columbia.edu   
Principal Investigator: Evelyn Attia, MD         
Weill Cornell Medical Center Recruiting
White Plains, New York, United States, 10605
Contact: Evelyn Attia, MD    914-997-8677    attiaev@med.cornell.edu   
Principal Investigator: Evelyn Attia, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Marsha Marcus, PhD    412-246-6371    marcusmd@upmc.edu   
Principal Investigator: Marsha Marcus, PhD         
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M5T1R8
Contact: Allan Kaplan, MD    416.535.8501 ext 4980    Allan_kaplan@camh.net   
Principal Investigator: Allan Kaplan, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Weill Medical College of Cornell University
University of Pittsburgh
Johns Hopkins University
University of Toronto
Investigators
Principal Investigator: Evelyn Attia, MD New York State Psychiatric Institute
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01170117     History of Changes
Other Study ID Numbers: #6142, R01MH085921
Study First Received: July 23, 2010
Last Updated: July 26, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Eating Disorders
Anorexia Nervosa

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014