NCT00685334

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2003

Typical duration for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 4, 2010

Completed
Last Updated

October 29, 2013

Status Verified

September 1, 2013

Enrollment Period

2.8 years

First QC Date

May 23, 2008

Results QC Date

August 3, 2009

Last Update Submit

September 25, 2013

Conditions

Eating Disorders

Keywords

Atypical AntipsychoticsAnorexia Nervosa

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Weight (Lbs.) at 12 Weeks

    This study looked at change in weight before and after medication use.

    baseline and 12 weeks

  • Tolerability

    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.

    Measured at Week 12

Secondary Outcomes (2)

  • Medication Side Effects

    Measured at Week 12

  • Treatment Compliance

    Measured at Week 12

Study Arms (2)

1

EXPERIMENTAL

Participants will take olanzapine

Drug: Olanzapine

2

ACTIVE COMPARATOR

Participants will take aripiprazole

Drug: Aripiprazole

Interventions

OlanzapineDRUG

Participants will take olanzapine daily for 12 weeks.

Also known as: zyprexa
1
AripiprazoleDRUG

Participants will take aripiprazole daily for 12 weeks.

Also known as: Abilify
2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

Related Links

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia Nervosa

Interventions

OlanzapineAripiprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperazinesHeterocyclic Compounds, 1-RingQuinolonesQuinolines

Results Point of Contact

Title
Evelyn Attia, MD
Organization
New York State Psychiatric Institute
ea12@columbia.edu
212-253-5923

Study Officials

  • Evelyn Attia, MD

    New York State Psychiatric Institute at Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

November 1, 2003

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

October 29, 2013

Results First Posted

February 4, 2010

Record last verified: 2013-09

Locations

CA(1)US(1)