Olanzapine Versus Placebo for Outpatients With Anorexia Nervosa

NCT01170117 | Completed Results DMC

• 2 other identifiers: #6142/7117RR01MH085921
• Study Type: interventional
• Target: 152
• Locations: 2 countries
• Sites: 5

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.

Conditions

Anorexia Nervosa

Keywords

Eating Disorders; Anorexia Nervosa

Outcome Measures

Primary Outcomes (2)

• Rate of Weight Change

  Comparison of rate of weight change between patients receiving olanzapine and those receiving placebo

  Weekly during 16-week trial and twice during 8 weeks follow-up

• Psychological Change

  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.

  Weekly during 16-week intervention and twice during 8-week follow-up

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Control group receiving placebo

Drug: Placebo

Olanzapine

EXPERIMENTAL

Group receiving olanzapine

Drug: Olanzapine

Interventions

Olanzapine DRUG

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.

Also known as: Zyprexa

Olanzapine

Placebo DRUG

Control Group will receive placebo pill

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator
• Weill Medical College of Cornell University: collaborator
• University of Pittsburgh: collaborator
• Johns Hopkins University: collaborator
• University of Toronto: collaborator

Study Sites (5)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Weill Cornell Medical Center

White Plains, New York, 10605, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T1R8, Canada

Location

Related Publications (2)

• 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. doi: 10.1176/appi.ajp.2008.07121900. Epub 2008 Jun 16.

  PMID: 18558642 BACKGROUND

• Attia E, Steinglass JE, Walsh BT, Wang Y, Wu P, Schreyer C, Wildes J, Yilmaz Z, Guarda AS, Kaplan AS, Marcus MD. Olanzapine Versus Placebo in Adult Outpatients With Anorexia Nervosa: A Randomized Clinical Trial. Am J Psychiatry. 2019 Jun 1;176(6):449-456. doi: 10.1176/appi.ajp.2018.18101125. Epub 2019 Jan 18.

  PMID: 30654643 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Evelyn Attia
• Organization: Columbia Center for Eating Disorders

ea12@cumc.columbia.edu

646-774-8085

Study Officials

• Evelyn Attia, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychaitrist

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 27, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 29, 2018
• Results First Posted: August 25, 2017

Record last verified: 2018-05

Locations

US (4); CA (1)