Eating Disorders Clinical Trial
Official title:
Atypical Antipsychotic Medication in Anorexia Nervosa
Verified date | April 2019 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.
Status | Completed |
Enrollment | 23 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Meets DSM-IV criteria (not including amenorrhea) for AN - Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2 - Patient (or family if the patient is a minor) refuses hospitalization - Free of psychotropic medication (4 weeks medication free for fluoxetine and antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry - Prior treatment of AN Exclusion Criteria: - Any medical or psychiatric problem requiring urgent attention and/or any significant comorbid illness not likely to benefit from proposed treatments - Allergy to olanzapine - Significant orthostatic high blood pressure - Recent commencement of psychotherapy in the community - Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose greater 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 |
Country | Name | City | State |
---|---|---|---|
United States | Eating Disorders Clinic, New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight Gain | Measured at Week 8 | ||
Secondary | 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. | Measured at Week 8 |
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