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| ID | Type | Description | Link |
|---|---|---|---|
| F31MH096433-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Setraline | Experimental | 250 mg DCS (setraline) versus placebo plus exposure |
|
| placebo | Placebo Comparator | Placebo group plus exposure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo vs Setraline | Drug | Placebo |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Twice a week for two weeks |
| 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. | twice a week for two weeks and at initial assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26132687 | Derived | Levinson CA, Rodebaugh TL, Fewell L, Kass AE, Riley EN, Stark L, McCallum K, Lenze EJ. D-Cycloserine facilitation of exposure therapy improves weight regain in patients with anorexia nervosa: a pilot randomized controlled trial. J Clin Psychiatry. 2015 Jun;76(6):e787-93. doi: 10.4088/JCP.14m09299. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Setraline | 250 mg DCS (setraline) Sertaline |
| FG001 | Placebo | Placebo group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Setraline | 250 mg DCS (setraline) versus placebo Sertaline |
| BG001 | Placebo | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | Twice a week for two weeks |
|
Adverse events were collected over 1 year.
There were no adverse events recorded for any participants who started or finished the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Setraline | 250 mg DCS (setraline) versus placebo Sertaline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheri Levinson | Washington University | 5023456483 | cherialevinson@wustl.edu |
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| ID | Term |
|---|---|
| D000855 | Anorexia |
| D052018 | Bulimia Nervosa |
| D002032 | Bulimia |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001068 | Feeding and Eating Disorders |
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| Setraline |
| Drug |
250mg DCS |
|
| Twice during 2 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
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| 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. | Posted | Mean | Standard Deviation | kg/m^2 | twice a week for two weeks and at initial assessment |
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| 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. | 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). | Posted | Mean | Standard Deviation | Units on a scale | Twice during 2 weeks |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Placebo group Sertaline | 0 | 16 | 0 | 16 |
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| D001523 | Mental Disorders |
| D006963 | Hyperphagia |