Trial Outcomes & Findings for Effectiveness of Olanzapine Versus Placebo in Treating Outpatients With Anorexia Nervosa (NCT NCT00692185)

NCT ID: NCT00692185

Last Updated: 2019-05-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Measured at Week 8
• Results posted on: 2019-05-10

Participant Flow

Participant milestones

Measure	Olanzapine Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.	Placebo Participants will take matched placebo for 8 weeks.
Overall Study STARTED	11	12
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Olanzapine Versus Placebo in Treating Outpatients With Anorexia Nervosa

Baseline characteristics by cohort

Measure	Olanzapine n=11 Participants Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.	Placebo n=12 Participants Participants will take matched placebo for 8 weeks.	Total n=23 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	11 Participants n=5 Participants	12 Participants n=7 Participants	23 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	28.6 years STANDARD_DEVIATION 9.9 • n=5 Participants	26.9 years STANDARD_DEVIATION 8.7 • n=7 Participants	27.7 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Week 8

Outcome measures

Measure	Olanzapine n=11 Participants Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.	Placebo n=12 Participants Participants will take matched placebo for 8 weeks.Dosing of placebo began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg . All subjects received 8 weeks of assigned medication.
Weight Gain	6.2 lbs Standard Deviation 6.6	1.5 lbs Standard Deviation 4.4

SECONDARY outcome

Timeframe: Measured at Week 8

Population: Individuals with anorexia nervosa

The Yale Brown Cornell-Eating Disorders Scale was used.This scale assesses severity of preoccupations and rituals. There are 8 questions that can be scored between 0-4 to indicate severity of symptoms, with 0 representing less severe and 4 representing most severe symptoms. The scores were summed, with possible results totaling 0-32.

Outcome measures

Measure	Olanzapine n=8 Participants Dosing of olanzapine began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg if the patient was tolerating the medication. If side effects were significant, dosage of the study medication could be lowered. All subjects received 8 weeks of assigned medication.	Placebo n=9 Participants Participants will take matched placebo for 8 weeks.Dosing of placebo began at 2.5 mg daily and was increased every two weeks, first to 5 mg, then 10 mg . All subjects received 8 weeks of assigned medication.
Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale	19.4 score on a scale Standard Deviation 8.1	18.9 score on a scale Standard Deviation 6.5

Adverse Events

Olanzapine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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: 212-543-5923

Email: ea12@columbia.edu

Results disclosure agreements

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