Eating Disorders
Conditions
Keywords
Atypical Antipsychotics, Anorexia Nervosa
Brief summary
This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.
Detailed description
Anorexia nervosa (AN) is a disease of disordered eating that is characterized by self-starvation, often leading to 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. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in treating people with AN. Specifically, the atypical antipsychotic medications olanzapine and aripiprazole may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of olanzapine and aripiprazole in treating people with AN. Participation in this study will last 12 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 12 weeks of treatment with daily olanzapine or aripiprazole. Participants will meet with a study doctor weekly over the 12 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. In addition, participants will undergo repeat blood draws every 4 weeks and repeat questionnaires every month of the treatment period. Upon completing the 12 weeks of treatment, participants will repeat most baseline assessments.
Interventions
DRUGOlanzapine
Participants will take olanzapine daily for 12 weeks.
DRUGAripiprazole
Participants will take aripiprazole daily for 12 weeks.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets DSM-IV criteria for AN (DSM-IV criteria for amenorrhea will not be strictly applied, as these patients have been shown to be clinically indistinguishable from those with full criteria AN) * Body mass index (BMI) less than 19 kg/m2 and greater than 14 kg/m2 (BMI of 19 is equivalent to approximately 85% of ideal body weight \[IBW\] according to Metropolitan Life standards, and BMI of 14 is equivalent to approximately 65% IBW) * Unwilling to pursue inpatient treatment if BMI is less than 18 kg/m2 * Free of psychotropic (e.g., antidepressant, antianxiety, mood stabilizer, antipsychotic) medication for 2 weeks before study entry (free for 4 weeks before study entry if taking fluoxetine or antipsychotic medications) * Prior treatment of AN
Exclusion criteria
* Any medical or psychiatric problem requiring urgent clinical attention (e.g., metabolic disturbance, acute suicidality) and/or significant comorbid illnesses that are not likely to benefit from proposed treatments * Significant orthostatic high blood pressure (systolic change greater than 30 mmHg upon changing from supine to standing position) * Allergy to olanzapine or aripiprazole * Commencing psychotherapy in the community within 3 months of study entry * Diabetes mellitus, with fasting serum glucose greater than 120 mg/dL or nonfasting serum glucose less 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 | Description |
|---|---|---|
| Change From Baseline in Weight (Lbs.) at 12 Weeks | baseline and 12 weeks | This study looked at change in weight before and after medication use. |
| Tolerability | Measured at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Side Effects | 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. |
| Treatment Compliance | Measured at Week 12 | Total number of randomized patients that completed the full 12 weeks of treatment. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 10 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Chose to enter hospital | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Olanzapine | Aripiprazole | 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 | 12 Participants | 10 Participants | 22 Participants |
| Age Continuous | 27.7 years STANDARD_DEVIATION 7.2 | 30.7 years STANDARD_DEVIATION 11.6 | 29.1 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment Canada | 5 participants | 4 participants | 9 participants |
| Region of Enrollment United States | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 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 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
Primary
Change From Baseline in Weight (Lbs.) at 12 Weeks
This study looked at change in weight before and after medication use.
Time frame: baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olanzapine | Change From Baseline in Weight (Lbs.) at 12 Weeks | 2.2 lbs | Standard Deviation 6.3 |
| Aripiprazole | Change From Baseline in Weight (Lbs.) at 12 Weeks | -1.2 lbs | Standard Deviation 5.1 |
Primary
Tolerability
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.
Time frame: Measured at Week 12
Population: Data was not available for all 22 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Tolerability | 8 Participants |
| Aripiprazole | Tolerability | 9 Participants |
Secondary
Medication Side Effects
Common side effects include sedation, dizziness, and headache for patients on olanzapine and akathisia, anxiety, dizziness and blurred vision for patients receiving aripriprazole.
Time frame: Measured at Week 12
Secondary
Treatment Compliance
Total number of randomized patients that completed the full 12 weeks of treatment.
Time frame: Measured at Week 12