Effectiveness of Olanzapine Versus Placebo in Treating 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. Identifier: NCT00692185
Recruitment Status : Completed
First Posted : June 6, 2008
Results First Posted : July 17, 2009
Last Update Posted : November 20, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.

Condition or disease Intervention/treatment Phase
Eating Disorders Drug: Olanzapine Drug: Placebo Phase 2

Detailed Description:

Anorexia nervosa (AN) is a disease of disordered eating and is characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. Symptoms and behaviors of AN may include distorted body image, obsessive exercise, lack of menstruation among women, binge and purge eating behaviors, and intense fear of weight gain. Furthermore, people with AN are at a high risk of other mental disorders, such as depression and anxiety, and medical complications, such as organ damage, heart failure, and osteoporosis. Current treatments for AN include nutrition counseling, psychotherapy, and medication. Although weight restoration is a treatment priority, no particular therapeutic approach for patients with AN has clear empirical support. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in increasing appetite and reducing anxiety related to weight gain and eating in people with AN. Specifically, the atypical antipsychotic medication olanzapine may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of the antipsychotic medication olanzapine versus placebo in treating outpatients with AN.

Participation in this study will last 8 weeks. All participants will first undergo baseline assessments that will include questionnaires and interviews about AN symptoms, a physical exam, vital sign measurements, an electrocardiograph (EKG), and a blood draw. Participants will then be assigned randomly to 8 weeks of daily treatment with olanzapine or placebo. Participants will meet with a study doctor weekly over the 8 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. Participants will also fill out weekly questionnaires about the status of their condition and monthly repeat baseline questionnaires. In addition, participants will undergo blood draws every 2 weeks for the first month of the study and every 4 weeks for the remainder of the study. Upon completing the 8 weeks of treatment, participants will repeat the baseline assessments. During the next 5 years, participants may be contacted to complete a follow-up interview.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atypical Antipsychotic Medication in Anorexia Nervosa
Study Start Date : October 2005
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Participants will take olanzapine.
Drug: Olanzapine
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.
Other Name: zyprexa

Placebo Comparator: 2
Participants will take matched placebo.
Drug: Placebo
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.

Primary Outcome Measures :
  1. Weight Gain [ Time Frame: Measured at Week 8 ]

Secondary Outcome Measures :
  1. Anxiety [ Time Frame: Measured at Week 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets DSM-IV criteria (not including amenorrhea) for AN
  • Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2
  • Patient (or family if the patient is a minor) refuses hospitalization
  • Free of psychotropic medication (4 weeks medication free for fluoxetine and antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry
  • Prior treatment of AN

Exclusion Criteria:

  • Any medical or psychiatric problem requiring urgent attention and/or any significant comorbid illness not likely to benefit from proposed treatments
  • Allergy to olanzapine
  • Significant orthostatic high blood pressure
  • Recent commencement of psychotherapy in the community
  • Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose greater than 140 mg/dL
  • Known history of current or past jaundice
  • Known history of narrow angle glaucoma
  • Active substance abuse or dependence
  • Schizophrenia, schizophreniform disorder, or bipolar illness
  • Movement disorder or presence of tics
  • History of tardive dyskinesia
  • History of seizures
  • Pregnant

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 identifier (NCT number): NCT00692185

United States, New York
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: Evelyn Attia, MD New York State Psychiatric Institute at Columbia University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute Identifier: NCT00692185     History of Changes
Other Study ID Numbers: #5116 (MH069868-02)
1R21MH069868-01 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2008    Key Record Dates
Results First Posted: July 17, 2009
Last Update Posted: November 20, 2017
Last Verified: October 2017

Keywords provided by New York State Psychiatric Institute:
Anorexia Nervosa

Additional relevant MeSH terms:
Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents