Phase 4
N=22
Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa
Eating Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00685334 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Change From Baseline in Weight (Lbs.) at 12 Weeks — 2.2; -1.2 lbs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olanzapine (Drug); Aripiprazole (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weight (Lbs.) at 12 Weeks |
2.2; -1.2 | — |
| PRIMARY Tolerability |
8; 9 | — |
| SECONDARY Medication Side Effects |
— | — |
| SECONDARY Treatment Compliance |
— | — |
Summary
This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00685334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.