Trial Outcomes & Findings for Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa (NCT NCT00685334)

NCT ID: NCT00685334

Last Updated: 2013-10-29

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 22 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2013-10-29

Participant Flow

Participant milestones

Measure	Olanzapine Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.	Aripiprazole Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
Overall Study STARTED	12	10
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Measure	Olanzapine Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.	Aripiprazole Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
Overall Study Withdrawal by Subject	5	6
Overall Study Lost to Follow-up	4	0
Overall Study Chose to enter hospital	1	1

Baseline Characteristics

Effectiveness of Atypical Antipsychotic Medication for Outpatients With Anorexia Nervosa

Baseline characteristics by cohort

Measure	Olanzapine n=12 Participants Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.	Aripiprazole n=10 Participants Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	27.7 years STANDARD_DEVIATION 7.2 • n=5 Participants	30.7 years STANDARD_DEVIATION 11.6 • n=7 Participants	29.1 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

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

Outcome measures

Measure	Olanzapine n=12 Participants Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.	Aripiprazole n=10 Participants Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
Change From Baseline in Weight (Lbs.) at 12 Weeks	2.2 lbs Standard Deviation 6.3	-1.2 lbs Standard Deviation 5.1

PRIMARY outcome

Timeframe: Measured at Week 12

Population: Data was not available for all 22 participants.

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.

Outcome measures

Measure	Olanzapine n=8 Participants Dosing of Olanzapine will begin at 2.5 mg and be increased every 2 weeks, first to 5 mg and then 10 mg, if the patient is tolerating the medication. Patients will remain on 10 mg for the final 8 weeks of the trial unless lower doses are necessary.	Aripiprazole n=9 Participants Aripiprazole dosing will begin at 5 mg daily, and will be increased every two weeks, first to 10 mg daily, then 15 mg daily for the final 8 weeks of the trial, unless lower doses are necessary.
Tolerability	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Measured at Week 12

Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Week 12

Total number of randomized patients that completed the full 12 weeks of treatment.

Outcome measures

Outcome data not reported

Adverse Events

Olanzapine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aripiprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Evelyn Attia, MD

New York State Psychiatric Institute

Phone: 212-253-5923

Email: ea12@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place