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Phase 4 N=22 Randomized Treatment

Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

Eating Disorders

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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