Anorexia Nervosa
Conditions
Keywords
Pilot Project,, Clinical Trial,, Treatment Outcome,, Psychopharmacology
Brief summary
The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.
Detailed description
The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the severity of the obsessive and/or anxiety symptoms associated with this disorder.
Interventions
DRUGOlanzapine
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.
BEHAVIORALDay 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.
Sponsors
Eli Lilly and Company
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* those who meet DSM IV criteria of Anorexia Nervosa- either restricting or binge/purge subtype
Exclusion criteria
* patients who are actively self destructive and/or suicidal * patients whose medical status is seriously compromised * patients whose eating disorder is superimposed on a major psychiatric disorder such as schizophrenia, major affective disorders, dissociative disorder or an active substance abuse disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) (kg/m^2) | Baseline (week 2) and post-treatment (week 13) | Body Mass Index (BMI) measured in kg/m\^2 units. Measured at Baseline (week 2) and post-treatment (week 13). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obsessions | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 16 |
| Total | 34 |
Baseline characteristics
| Characteristic | Placebo Plus Day Hospital | Olanzapine Plus Day Hospital | Total |
|---|---|---|---|
| Age, Continuous | 29.67 years STANDARD_DEVIATION 11.59 | 23.61 years STANDARD_DEVIATION 6.5 | 27.03 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
Body Mass Index (BMI) (kg/m^2)
Body Mass Index (BMI) measured in kg/m\^2 units. Measured at Baseline (week 2) and post-treatment (week 13).
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Plus Day Hospital | Body Mass Index (BMI) (kg/m^2) | Week 2 baseline | 19.66 kg/m^2 | Standard Deviation 1.32 |
| Placebo Plus Day Hospital | Body Mass Index (BMI) (kg/m^2) | Week 13 | 19.66 kg/m^2 | Standard Deviation 1.32 |
| Olanzapine Plus Day Hospital | Body Mass Index (BMI) (kg/m^2) | Week 2 baseline | 20.30 kg/m^2 | Standard Deviation 0.99 |
| Olanzapine Plus Day Hospital | Body Mass Index (BMI) (kg/m^2) | Week 13 | 20.30 kg/m^2 | Standard Deviation 0.99 |
Secondary
Obsessions
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.
Time frame: Pretreatment (Week 1) and Posttreatment (Week 13)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Plus Day Hospital | Obsessions | Pretreatment | 9.11 units on a scale | Standard Deviation 5.58 |
| Placebo Plus Day Hospital | Obsessions | Posttreatment | 5.86 units on a scale | Standard Deviation 4.83 |
| Olanzapine Plus Day Hospital | Obsessions | Pretreatment | 11.06 units on a scale | Standard Deviation 3.96 |
| Olanzapine Plus Day Hospital | Obsessions | Posttreatment | 6.54 units on a scale | Standard Deviation 4.29 |