Anorexia and Bulimia Nervosa
Conditions
Keywords
Anorexia, Bulimia, Anxiety, Exposure
Brief summary
This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.
Detailed description
This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.
Interventions
DRUGPlacebo vs Setraline
Placebo
DRUGSetraline
250mg DCS
Sponsors
National Institute of Mental Health (NIMH)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified
Exclusion criteria
* Pregnant or planning on becoming pregnant * Psychotic or Manic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). | Twice a week for two weeks | Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition. Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced. |
| Body Mass Index | twice a week for two weeks and at initial assessment | BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fear of Food Measure | Twice during 2 weeks | The Fear of Food Measure (FOFM) was designed to assess three cognitive behavioral components related to mealtime anxiety. All items are rated on a 1 to 7 Likert-type scale ranging from not at all to very much so. Higher values indicate worse outcomes. The first subscale is the anxiety about eating subscale, which was designed to assess trait levels of fear and anxiety surrounding eating and food. This subscale will be measured once before and after the trial (twice in 2 weeks). Each item (8 items totaled, each scored 1-7; max possible score is 56; min possible score is 8) was added for each time point and time points were averaged together for all participants for both time points. |
Countries
United States
Participant flow
Pre-assignment details
47 participants were enrolled in the study, but only 36 were randomized and given any medication or placebo (i.e., participants completed the assessment portion of the study but did not move to the active experimental portion of the study).
Participants by arm
| Arm | Count |
|---|---|
| Setraline 250 mg DCS (setraline) versus placebo
Sertaline | 20 |
| Placebo Placebo Group | 16 |
| Total | 36 |
Baseline characteristics
| Characteristic | Setraline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 14 Participants | 31 Participants |
| Age, Continuous | 26.10 years | 24.63 years | 25.44 years |
| BMI | 20.10 kg/m^2 STANDARD_DEVIATION 2.13 | 20.44 kg/m^2 STANDARD_DEVIATION 1.91 | 20.25 kg/m^2 STANDARD_DEVIATION 2.09 |
| Region of Enrollment United States | 20 participants | 16 participants | 36 participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 35 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 | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 16 |
| serious Total, serious adverse events | 0 / 20 | 0 / 16 |
Outcome results
Primary
Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).
Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition. Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced.
Time frame: Twice a week for two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setraline | Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). | 52.395 Units on a scale | Standard Deviation 5.493 |
| Placebo | Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100). | 58.983 Units on a scale | Standard Deviation 6.141 |
Primary
Body Mass Index
BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome.
Time frame: twice a week for two weeks and at initial assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setraline | Body Mass Index | .385 kg/m^2 | Standard Deviation 0.3 |
| Placebo | Body Mass Index | .095 kg/m^2 | Standard Deviation 0.3 |
p-value: 0.043ANOVA
Other Pre-specified
Fear of Food Measure
The Fear of Food Measure (FOFM) was designed to assess three cognitive behavioral components related to mealtime anxiety. All items are rated on a 1 to 7 Likert-type scale ranging from not at all to very much so. Higher values indicate worse outcomes. The first subscale is the anxiety about eating subscale, which was designed to assess trait levels of fear and anxiety surrounding eating and food. This subscale will be measured once before and after the trial (twice in 2 weeks). Each item (8 items totaled, each scored 1-7; max possible score is 56; min possible score is 8) was added for each time point and time points were averaged together for all participants for both time points.
Time frame: Twice during 2 weeks
Population: All combined represents the total number of participants (n=40); however 4 participants withdrew. Analysis utilized data for 36 participants who started in participant flow, thus (n=36).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setraline | Fear of Food Measure | 19.55 Units on a scale | Standard Deviation 5.6 |
| Placebo | Fear of Food Measure | 21.22 Units on a scale | Standard Deviation 5.8 |
| All Combined | Fear of Food Measure | 20.01 Units on a scale | Standard Deviation 5.7 |