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

July 23, 2010
July 26, 2013
August 2010
June 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01170117 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa
Olanzapine vs Placebo for Outpatients With Anorexia Nervosa

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anorexia Nervosa
  • 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
  • Drug: Placebo
    Control Group will receive placebo pill
  • Placebo Comparator: Placebo
    Control group receiving placebo
    Intervention: Drug: Placebo
  • Experimental: Olanzapine
    Group receiving olanzapine
    Intervention: Drug: Olanzapine
Bissada H, Tasca GA, Barber AM, Bradwejn J. Olanzapine in the treatment of low body weight and obsessive thinking in women with anorexia nervosa: a randomized, double-blind, placebo-controlled trial. Am J Psychiatry. 2008 Oct;165(10):1281-8. Epub 2008 Jun 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
June 2015
June 2015   (final data collection date for primary outcome measure)

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.)
Both
18 Years to 55 Years
No
Contact: Meg Martinez, BS 212.543.5739 edru@pi.cpmc.columbia.edu
United States,   Canada
 
NCT01170117
#6142, R01MH085921
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
  • National Institute of Mental Health (NIMH)
  • Weill Medical College of Cornell University
  • University of Pittsburgh
  • Johns Hopkins University
  • University of Toronto
Principal Investigator: Evelyn Attia, MD New York State Psychiatric Institute
New York State Psychiatric Institute
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP