Trial Outcomes & Findings for Olanzapine in the Treatment of Patients With Anorexia Nervosa (NCT NCT00260962)
NCT ID: NCT00260962
Last Updated: 2018-01-30
Results Overview
Body Mass Index (BMI) measured in kg/m\^2 units. Measured at Baseline (week 2) and post-treatment (week 13).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Baseline (week 2) and post-treatment (week 13)
Results posted on
2018-01-30
Participant Flow
Eligible participants were recruited from patients referred to the eating disorders program at The Ottawa Hospital by a family physician or psychiatrist between September 2000 and April 2006.
Participant milestones
| Measure |
Placebo Plus Day Hospital
After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
|
Olanzapine Plus Day Hospital
After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Olanzapine in the Treatment of Patients With Anorexia Nervosa
Baseline characteristics by cohort
| Measure |
Placebo Plus Day Hospital
n=18 Participants
After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
|
Olanzapine Plus Day Hospital
n=16 Participants
After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.67 years
STANDARD_DEVIATION 11.59 • n=99 Participants
|
23.61 years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
27.03 years
STANDARD_DEVIATION 9.90 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 2) and post-treatment (week 13)Population: 4 participants discontinued in placebo group and 2 did not have weight measurements at week 13. 2 participants discontinued in the olanzapine group
Body Mass Index (BMI) measured in kg/m\^2 units. Measured at Baseline (week 2) and post-treatment (week 13).
Outcome measures
| Measure |
Placebo Plus Day Hospital
n=12 Participants
After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
|
Olanzapine Plus Day Hospital
n=16 Participants
After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
|
|---|---|---|
|
Body Mass Index (BMI) (kg/m^2)
Week 2 baseline
|
19.66 kg/m^2
Standard Deviation 1.32
|
20.30 kg/m^2
Standard Deviation 0.99
|
|
Body Mass Index (BMI) (kg/m^2)
Week 13
|
19.66 kg/m^2
Standard Deviation 1.32
|
20.30 kg/m^2
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Pretreatment (Week 1) and Posttreatment (Week 13)Obsessions subscale of the Yale-Brown Obsessive Compulsive Scale. Minimum score is 0 and maximum score is 20. Higher scores indicate higher levels of obsessions.
Outcome measures
| Measure |
Placebo Plus Day Hospital
n=18 Participants
After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
|
Olanzapine Plus Day Hospital
n=16 Participants
After a 2-week baseline period, Olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of 10 mg/day. Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
Olanzapine: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day.
Day Hospital: Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy.
|
|---|---|---|
|
Obsessions
Pretreatment
|
9.11 units on a scale
Standard Deviation 5.58
|
11.06 units on a scale
Standard Deviation 3.96
|
|
Obsessions
Posttreatment
|
5.86 units on a scale
Standard Deviation 4.83
|
6.54 units on a scale
Standard Deviation 4.29
|
Adverse Events
Placebo Plus Day Hospital
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Olanzapine Plus Day Hospital
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place