A Phase 4 interventional study of Olanzapine and Aripiprazole in Eating Disorders, sponsored by New York State Psychiatric Institute. Completed at 2 sites in 2 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-10-29.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment
This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.
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.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's enrollment of 22 is below the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
Participants will take olanzapine
Drug: Olanzapine
Participants will take aripiprazole
Drug: Aripiprazole
Participants will take olanzapine daily for 12 weeks.
Also known as: zyprexa
Participants will take aripiprazole daily for 12 weeks.
Also known as: Abilify
Change From Baseline in Weight (Lbs.) at 12 Weeks
This study looked at change in weight before and after medication use.
Time frame: 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.
Time frame: Measured at Week 12
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.
Time frame: Measured at Week 12
Treatment Compliance
Total number of randomized patients that completed the full 12 weeks of treatment.
Time frame: Measured at Week 12
| Milestone | Olanzapine | Aripiprazole |
|---|---|---|
| Started | 12 | 10 |
| Completed | 2 | 3 |
| Not completed | 10 | 7 |
| Withdrew: Withdrawal by subject | 5 | 6 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Withdrew: Chose to enter hospital | 1 | 1 |
This study looked at change in weight before and after medication use.
| lbs | Olanzapine | Aripiprazole |
|---|---|---|
| Change From Baseline in Weight (Lbs.) at 12 Weeks | 2.2 ± 6.3 | -1.2 ± 5.1 |
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.
| Participants | Olanzapine | Aripiprazole |
|---|---|---|
| Tolerability | 8 | 9 |
Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.
Results for this outcome have not been posted.
Total number of randomized patients that completed the full 12 weeks of treatment.
Results for this outcome have not been posted.
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olanzapine | — | 0/12 (0%) | 0/12 (0%) |
| Aripiprazole | — | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Olanzapine | Aripiprazole | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 10 | 22 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Olanzapine | Aripiprazole | Total |
|---|---|---|---|
| Mean | 27.7 ± 7.2 | 30.7 ± 11.6 | 29.1 ± 9.3 |
| Sex: Female, Male(Participants) | Olanzapine | Aripiprazole | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Olanzapine | Aripiprazole | Total |
|---|---|---|---|
| United States | 7 | 6 | 13 |
| Canada | 5 | 4 | 9 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute