Effectiveness of Atypical Antipsychotic Medication 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. Identifier: NCT00685334
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : February 4, 2010
Last Update Posted : October 29, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.

Condition or disease Intervention/treatment Phase
Eating Disorders Drug: Olanzapine Drug: Aripiprazole Phase 4

Detailed Description:

Anorexia nervosa (AN) is a disease of disordered eating that is characterized by self-starvation, often leading to 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. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in treating people with AN. Specifically, the atypical antipsychotic medications olanzapine and aripiprazole may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of olanzapine and aripiprazole in treating people with AN.

Participation in this study will last 12 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 12 weeks of treatment with daily olanzapine or aripiprazole. Participants will meet with a study doctor weekly over the 12 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. In addition, participants will undergo repeat blood draws every 4 weeks and repeat questionnaires every month of the treatment period. Upon completing the 12 weeks of treatment, participants will repeat most baseline assessments.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa
Study Start Date : November 2003
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Participants will take olanzapine
Drug: Olanzapine
Participants will take olanzapine daily for 12 weeks.
Other Name: zyprexa

Active Comparator: 2
Participants will take aripiprazole
Drug: Aripiprazole
Participants will take aripiprazole daily for 12 weeks.
Other Name: Abilify

Primary Outcome Measures :
  1. Change From Baseline in Weight (Lbs.) at 12 Weeks [ Time Frame: baseline and 12 weeks ]
    This study looked at change in weight before and after medication use.

  2. Tolerability [ Time Frame: Measured at Week 12 ]
    This study addressed the benefits, tolerability, acceptability, safety, and appropriate dosage of olanzapine and aripiprazole, as determined by clinical evaluation and self report. The outcome measure reported here is the number of patients who did not experience untoward side effects while taking the medication.

Secondary Outcome Measures :
  1. Medication Side Effects [ Time Frame: Measured at Week 12 ]
    Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.

  2. Treatment Compliance [ Time Frame: Measured at Week 12 ]
    Total number of randomized patients that completed the full 12 weeks of treatment.

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 for AN (DSM-IV criteria for amenorrhea will not be strictly applied, as these patients have been shown to be clinically indistinguishable from those with full criteria AN)
  • Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2 (BMI of 19 is equivalent to approximately 85% of ideal body weight [IBW] according to Metropolitan Life standards, and BMI of 14 is equivalent to approximately 65% IBW)
  • Unwilling to pursue inpatient treatment if BMI is less than 18 kg/m2
  • Free of psychotropic (e.g., antidepressant, antianxiety, mood stabilizer, antipsychotic) medication for 2 weeks before study entry (free for 4 weeks before study entry if taking fluoxetine or antipsychotic medications)
  • Prior treatment of AN

Exclusion Criteria:

  • Any medical or psychiatric problem requiring urgent clinical attention (e.g., metabolic disturbance, acute suicidality) and/or significant comorbid illnesses that are not likely to benefit from proposed treatments
  • Significant orthostatic high blood pressure (systolic change greater than 30 mmHg upon changing from supine to standing position)
  • Allergy to olanzapine or aripiprazole
  • Commencing psychotherapy in the community within 3 months of study entry
  • Diabetes mellitus, with fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose less 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): NCT00685334

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G2C4
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

Additional Information:
Responsible Party: New York State Psychiatric Institute Identifier: NCT00685334     History of Changes
Other Study ID Numbers: #4696 (MH069868-01)
1R21MH069868-01 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2008    Key Record Dates
Results First Posted: February 4, 2010
Last Update Posted: October 29, 2013
Last Verified: September 2013

Keywords provided by New York State Psychiatric Institute:
Atypical Antipsychotics
Anorexia Nervosa

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