Eating Disorders
Conditions
Keywords
Anorexia Nervosa
Brief summary
This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.
Detailed description
Anorexia nervosa (AN) is a disease of disordered eating and is characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. Symptoms and behaviors of AN may include distorted body image, obsessive exercise, lack of menstruation among women, binge and purge eating behaviors, and intense fear of weight gain. Furthermore, people with AN are at a high risk of other mental disorders, such as depression and anxiety, and medical complications, such as organ damage, heart failure, and osteoporosis. Current treatments for AN include nutrition counseling, psychotherapy, and medication. Although weight restoration is a treatment priority, no particular therapeutic approach for patients with AN has clear empirical support. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in increasing appetite and reducing anxiety related to weight gain and eating in people with AN. Specifically, the atypical antipsychotic medication olanzapine may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of the antipsychotic medication olanzapine versus placebo in treating outpatients with AN. Participation in this study will last 8 weeks. All participants will first undergo baseline assessments that will include questionnaires and interviews about AN symptoms, a physical exam, vital sign measurements, an electrocardiograph (EKG), and a blood draw. Participants will then be assigned randomly to 8 weeks of daily treatment with olanzapine or placebo. Participants will meet with a study doctor weekly over the 8 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. Participants will also fill out weekly questionnaires about the status of their condition and monthly repeat baseline questionnaires. In addition, participants will undergo blood draws every 2 weeks for the first month of the study and every 4 weeks for the remainder of the study. Upon completing the 8 weeks of treatment, participants will repeat the baseline assessments. During the next 5 years, participants may be contacted to complete a follow-up interview.
Interventions
DRUGOlanzapine
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks.
DRUGPlacebo
Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets DSM-IV criteria (not including amenorrhea) for AN * Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2 * Patient (or family if the patient is a minor) refuses hospitalization * Free of psychotropic medication (4 weeks medication free for fluoxetine and antipsychotic medication; 2 weeks medication free for all others) OR on a stable dose of an SSRI or SNRI (venlafaxine) for 4 weeks before study entry * Prior treatment of AN
Exclusion criteria
* Any medical or psychiatric problem requiring urgent attention and/or any significant comorbid illness not likely to benefit from proposed treatments * Allergy to olanzapine * Significant orthostatic high blood pressure * Recent commencement of psychotherapy in the community * Diabetes mellitus, with a fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose greater 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Gain | Measured at Week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale | Measured at Week 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Placebo Participants will take matched placebo for 8 weeks. | 12 |
| Total | 23 |
Baseline characteristics
| Characteristic | Olanzapine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 12 Participants | 23 Participants |
| Age, Continuous | 28.6 years STANDARD_DEVIATION 9.9 | 26.9 years STANDARD_DEVIATION 8.7 | 27.7 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment Canada | 3 participants | 4 participants | 7 participants |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 0 / 11 | 0 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
Weight Gain
Time frame: Measured at Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olanzapine | Weight Gain | 6.2 lbs | Standard Deviation 6.6 |
| Placebo | Weight Gain | 1.5 lbs | Standard Deviation 4.4 |
Secondary
Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale
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.
Time frame: Measured at Week 8
Population: Individuals with anorexia nervosa
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olanzapine | Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale | 19.4 score on a scale | Standard Deviation 8.1 |
| Placebo | Symptom Severity Assessed by Yale Brown Cornell-Eating Disorders Scale | 18.9 score on a scale | Standard Deviation 6.5 |