Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

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

Study Overview

• Status: Completed
• Conditions: Eating Disorders
• Intervention / Treatment: Drug: Olanzapine; Drug: Aripiprazole

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
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants will take olanzapine	Drug: Olanzapine; Participants will take olanzapine daily for 12 weeks.; Other Names: zyprexa
Active Comparator: 2; Participants will take aripiprazole	Drug: Aripiprazole; Participants will take aripiprazole daily for 12 weeks.; Other Names: Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Weight (Lbs.) at 12 Weeks	This study looked at change in weight before and after medication use.	baseline and 12 weeks
Tolerability	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.	Measured at Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Side Effects	Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.	Measured at Week 12
Treatment Compliance	Total number of randomized patients that completed the full 12 weeks of treatment.	Measured at Week 12

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: May 23, 2008
• First Submitted That Met QC Criteria: May 23, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: September 25, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Atypical Antipsychotics; Anorexia Nervosa
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anorexia; Anorexia Nervosa; Feeding and Eating Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Olanzapine; Aripiprazole
• Other Study ID Numbers: #4696 (MH069868-01); 1R21MH069868-01 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No