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Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01170117
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : August 25, 2017
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
University of Pittsburgh
Johns Hopkins University
University of Toronto
Information provided by (Responsible Party):
Evelyn Attia, New York State Psychiatric Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: Olanzapine Drug: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Olanzapine vs Placebo for Outpatients With Anorexia Nervosa
Actual Study Start Date : August 2010
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Weight Change [ Time Frame: Weekly during 16-week trial and twice during 8 weeks follow-up ]
    Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo

  2. Psychological Change [ Time Frame: Weekly during 16-week intervention and twice during 8-week follow-up ]
    Comparison of psychological change as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS), in patients receiving olanzapine compared with those receiving placebo. The Y-BOCS is divided into two sections: obsessive and compulsive. The scores for each section range from 1 to 20. The overall scores are obtained from adding scores for the two sections, to obtain a range between 2-40. A lower score reflects improvement/ fewer obsessive compulsive symptoms. A score of 25 or more is considered moderately severe, a score of 30 or more is considered severe, and a score of more than 35 is considered very severe.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Anorexia Nervosa
  • Body Mass Index (BMI) between 14.0 and 18.5 kg/m2
  • Between 18-75 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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170117


Locations
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United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Weill Cornell Medical Center
White Plains, New York, United States, 10605
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T1R8
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Evelyn Attia, MD New York State Psychiatric Institute
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Evelyn Attia, Clinical Psychaitrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01170117    
Other Study ID Numbers: #6142/7117R
R01MH085921 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2010    Key Record Dates
Results First Posted: August 25, 2017
Last Update Posted: June 29, 2018
Last Verified: May 2018
Keywords provided by Evelyn Attia, New York State Psychiatric Institute:
Eating Disorders
Anorexia Nervosa
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents