Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

NCT ID: NCT00685334

Last Updated: 2013-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2006-09-30

Brief Summary

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

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.

Conditions

Eating Disorders

Keywords

Atypical Antipsychotics; Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Participants will take olanzapine

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

Participants will take olanzapine daily for 12 weeks.

2

Participants will take aripiprazole

Group Type: ACTIVE_COMPARATOR

Aripiprazole

Intervention Type: DRUG

Participants will take aripiprazole daily for 12 weeks.

Interventions

Olanzapine

Participants will take olanzapine daily for 12 weeks.

Intervention Type: DRUG

Aripiprazole

Participants will take aripiprazole daily for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

zyprexa; Abilify

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evelyn Attia, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute at Columbia University Medical Center

Locations

New York State Psychiatric Institute

New York, New York, United States

Toronto General Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

Related Links

http://www.eatingdisordersclinic.org

Click here for more information about this study at the Eating Disorders Research Clinic

Other Identifiers

1R21MH069868-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#4696 (MH069868-01)

Identifier Type: -

Identifier Source: org_study_id