Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

Eating Disorders Clinical Trial

Official title:

Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685334
• Other study ID #: #4696 (MH069868-01)
• Secondary ID: 1R21MH069868-01
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2008
• Last updated: September 25, 2013
• Start date: November 2003
• Est. completion date: September 2006

Study information

• Verified date: September 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Eating Disorders

Intervention

Drug:
• Olanzapine
Participants will take olanzapine daily for 12 weeks.
• Aripiprazole
Participants will take aripiprazole daily for 12 weeks.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Treatment Compliance	Total number of randomized patients that completed the full 12 weeks of treatment.	Measured at Week 12	No