A Phase 2 interventional study of Olanzapine and Placebo in Eating Disorders, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-05-10.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment
This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.
Anorexia nervosa (AN) is a disease of disordered eating and is characterized by self-starvation, 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. Although weight restoration is a treatment priority, no particular therapeutic approach for patients with AN has clear empirical support. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in increasing appetite and reducing anxiety related to weight gain and eating in people with AN. Specifically, the atypical antipsychotic medication olanzapine may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of the antipsychotic medication olanzapine versus placebo in treating outpatients with AN.
Participation in this study will last 8 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 8 weeks of daily treatment with olanzapine or placebo. Participants will meet with a study doctor weekly over the 8 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. Participants will also fill out weekly questionnaires about the status of their condition and monthly repeat baseline questionnaires. In addition, participants will undergo blood draws every 2 weeks for the first month of the study and every 4 weeks for the remainder of the study. Upon completing the 8 weeks of treatment, participants will repeat the baseline assessments. During the next 5 years, participants may be contacted to complete a follow-up interview.
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's enrollment of 23 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will take olanzapine.
Drug: Olanzapine
Participants will take matched placebo.
Drug: Placebo
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.
Also known as: zyprexa
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.
Weight Gain
Time frame: Measured at Week 8
Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale
The Yale Brown Cornell-Eating Disorders Scale was used.This scale assesses severity of preoccupations and rituals. There are 8 questions that can be scored between 0-4 to indicate severity of symptoms, with 0 representing less severe and 4 representing most severe symptoms. The scores were summed, with possible results totaling 0-32.
Time frame: Measured at Week 8
| Milestone | Olanzapine | Placebo |
|---|---|---|
| Started | 11 | 12 |
| Completed | 8 | 9 |
| Not completed | 3 | 3 |
| lbs | Olanzapine | Placebo |
|---|---|---|
| Weight Gain | 6.2 ± 6.6 | 1.5 ± 4.4 |
The Yale Brown Cornell-Eating Disorders Scale was used.This scale assesses severity of preoccupations and rituals. There are 8 questions that can be scored between 0-4 to indicate severity of symptoms, with 0 representing less severe and 4 representing most severe symptoms. The scores were summed, with possible results totaling 0-32.
| score on a scale | Olanzapine | Placebo |
|---|---|---|
| Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale | 19.4 ± 8.1 | 18.9 ± 6.5 |
Collected over 8 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olanzapine | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Placebo | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Olanzapine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 12 | 23 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Olanzapine | Placebo | Total |
|---|---|---|---|
| Mean | 28.6 ± 9.9 | 26.9 ± 8.7 | 27.7 ± 9.1 |
| Sex: Female, Male(Participants) | Olanzapine | Placebo | Total |
|---|---|---|---|
| Female | 10 | 12 | 22 |
| Male | 1 | 0 | 1 |
| Region of Enrollment(participants) | Olanzapine | Placebo | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
| Canada | 3 | 4 | 7 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute