Status:
COMPLETED
Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Weill Medical College of Cornell University
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
18-75 years
Phase:
NA
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.
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 olanzap...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01170117
Start Date
August 1 2010
End Date
June 1 2017
Last Update
June 29 2018
Active Locations (5)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21287
2
New York State Psychiatric Institute
New York, New York, United States, 10032
3
Weill Cornell Medical Center
White Plains, New York, United States, 10605
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213