Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

Completed · Not applicable · Has a placebo group

Conditions studied: Anorexia Nervosa

In brief

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

Key facts

Study ID

NCT01170117

Run by

New York State Psychiatric Institute

People needed

152

Starts

2010-08-01

Expected to finish

2017-06-01

Last updated by the study team

2018-06-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.)

Where it is running

• Johns Hopkins — Baltimore, Maryland, United States
• New York State Psychiatric Institute — New York, New York, United States
• Weill Cornell Medical Center — White Plains, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Centre for Addiction and Mental Health — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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