Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00685334
First received: May 23, 2008
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Eating Disorders
Drug: Olanzapine
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Change From Baseline in Weight (Lbs.) at 12 Weeks [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    This study looked at change in weight before and after medication use.

  • Tolerability [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
    This study addressed the benefits, tolerability, acceptability, safety, and appropriate dosage of olanzapine and aripiprazole, as determined by clinical evaluation and self report. The outcome measure reported here is the number of patients who did not experience untoward side effects while taking the medication.


Secondary Outcome Measures:
  • Medication Side Effects [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
    Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.

  • Treatment Compliance [ Time Frame: Measured at Week 12 ] [ Designated as safety issue: No ]
    Total number of randomized patients that completed the full 12 weeks of treatment.


Enrollment: 22
Study Start Date: November 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will take olanzapine
Drug: Olanzapine
Participants will take olanzapine daily for 12 weeks.
Other Name: zyprexa
Active Comparator: 2
Participants will take aripiprazole
Drug: Aripiprazole
Participants will take aripiprazole daily for 12 weeks.
Other Name: Abilify

Detailed Description:

Anorexia nervosa (AN) is a disease of disordered eating that is characterized by self-starvation, often leading to 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. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in treating people with AN. Specifically, the atypical antipsychotic medications olanzapine and aripiprazole may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of olanzapine and aripiprazole in treating people with AN.

Participation in this study will last 12 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 12 weeks of treatment with daily olanzapine or aripiprazole. Participants will meet with a study doctor weekly over the 12 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. In addition, participants will undergo repeat blood draws every 4 weeks and repeat questionnaires every month of the treatment period. Upon completing the 12 weeks of treatment, participants will repeat most baseline assessments.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685334

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G2C4
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Evelyn Attia, MD New York State Psychiatric Institute at Columbia University Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00685334     History of Changes
Other Study ID Numbers: #4696 (MH069868-01), 1R21MH069868-01
Study First Received: May 23, 2008
Results First Received: August 3, 2009
Last Updated: September 25, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Atypical Antipsychotics
Anorexia Nervosa

Additional relevant MeSH terms:
Anorexia
Eating Disorders
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Aripiprazole
Antipsychotic Agents
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on October 19, 2014