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Phase 4 Completed N=22 Randomized Treatment

Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

Source: ClinicalTrials.gov NCT00685334 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Change From Baseline in Weight (Lbs.) at 12 Weeks — 2.2; -1.2 lbs

Summary

This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.

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

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. Informational only — not medical advice.

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