Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa|
- Change From Baseline in Weight (Lbs.) at 12 Weeks [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]This study looked at change in weight before and after medication use.
- Tolerability [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]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.
- Medication Side Effects [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.
- Treatment Compliance [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]Total number of randomized patients that completed the full 12 weeks of treatment.
|Study Start Date:||November 2003|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Participants will take olanzapine
Participants will take olanzapine daily for 12 weeks.
Other Name: zyprexa
Active Comparator: 2
Participants will take aripiprazole
Participants will take aripiprazole daily for 12 weeks.
Other Name: Abilify
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685334
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G2C4|
|Principal Investigator:||Evelyn Attia, MD||New York State Psychiatric Institute at Columbia University Medical Center|