Bulimia Nervosa, Stress Disorders, Post-Traumatic
Conditions
Keywords
Eating Disorders, Bulimia Nervosa, Nightmares, Post Traumatic Stress Disorder
Brief summary
This research is being done to find out how effective Prazosin is in the treatment of bulimic patients experiencing distressing nightmares using subjective and objective measures.
Detailed description
To the investigators knowledge, there is no treatment trial for prazosin use in patients with bulimia nervosa struggling with nightmares, looking at either objective or subjective measures. The investigators plan to probe the effectiveness of prazosin in bulimic patients experiencing nightmares due to PTSD using both subjective and objective measures in order to improve future clinical care. The effects of prazosin on decreasing nightmares and bulimic symptoms on subjective scales and effects on sleep architecture using objective polysomnogram (PSG) measurements will help inform targeted psychopharmacologic and psychotherapeutic strategies to improve clinical care of bulimic patients struggling with distressing dreams secondary to PTSD. This study will be performed in two phases. Phase A will involve eight participants who will be tested using subjective scales (mentioned below). If Phase A data analysis leads to detection of a signal of efficacy 2 more participants will be recruited to participate in phase B of this trial using objective polysomnogram measurements. The results from this project will aid in establishing a fully powered clinical trial for treatment of nightmares in bulimic patients and improve outcomes in this high risk population.
Interventions
DRUGPrazosin
A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.
DRUGPlacebo
Prazosin-matched placebo pill
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-45 * Clinical diagnosis of Bulimia Nervosa with complaint of nightmares secondary to PTSD
Exclusion criteria
* Restless leg syndrome * Narcolepsy * Sleep Apnea * Neurological disorders * Pregnancy * cardiac abnormalities * significant electrolyte abnormalities * Use of steroids, beta blockers, prazosin * Alcohol/substance abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire | 3 weeks | The individual question about frightening dreams from the Nightmares Subscale of a self-administered questionnaire (Sleep-50 Questionnaire), will be used to determine if there is a decrease in frequency of nightmares in patients undergoing drug intervention. For each question, respondents are provided with a scale ranging from 1 (not at all) to 4 (very much) and are asked to indicate the extent to which the statement has matched their experience over the study time frame. The scale values range from 1-4, where a lower value indicates lower frequency of nightmares. A higher score is a worse outcome. |
| Decrease in Rapid Eye Movement (REM) Density & Normalization of REM Disruptions | 3 weeks | PSG (Polysomnogram) will be used in 2 participants to determine if there is a decrease in REM density in patients undergoing drug intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Bulimia Symptoms | 3 weeks | EDI-3 (Eating Disorder Inventory 3 Scale) is a pencil and paper test consisting of 91 items and 12 sub-scales. The main scales are the drive for thinness and the bulimia scales, the remaining sub-scales are: low self-esteem, body dissatisfaction, maturity fears, personal alienation, interpersonal alienation, interpersonal insecurity, perfectionism, interoceptive deficits, emotional dysregulation, and asceticism. The response options are based on a 6-point Likert-type scale are: Always, Usually, Often, Sometimes, Rarely, and Never. There are six composite scores, 12 primary scores, and three response style validity indicators. Software is used to calculate the raw scores, composite scores, validity scale scores and the T-scores. The t-score for the Bulimia scale will be used for this analysis with a range of 22-66. Higher scores indicate the likelihood of an eating disorder. A higher t-score on the bulimia scale indicates a worse outcome. |
| Decrease in Total CAPS Score (PTSD) | 3 weeks | The CAPS (Clinician administered PTSD) rating scale consists of 30 questions rated on a 0-4 point scoring system and patient interview will be used to determine if there is a decrease in PTSD Symptoms among participants undergoing drug intervention. 17 of these questions are used to calculate the total severity score used in this analysis. This is done by summing the frequency and intensity ratings (each ranging from 0-4) for each of the 17 questions. The total severity score can have a range of 0-136. A higher score on this scale indicates a worse outcome. |
| Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview | 3 weeks | Rating scales and subject interview will be used to determine if there is a decrease in depressed mood among participants undergoing drug intervention. The HDRS (Hamilton Depression Rating Scale) consists of 17 items, some scored on a 5-point scale (0-4) and others scored on a 3-point scale (0-2). Items from the scale can be summed to give a total score ranging from 0 to 50, with higher scores indicating a worse outcome. This analysis is based on a single item from the scale (Depressed Mood, measured on a 5-point scale) where a higher score again indicates a worse outcome. |
| Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview | 3 weeks | Rating scales and subject interview will be used to determine if there is a decrease in self harm among participants undergoing drug intervention. The HDRS (Hamilton Depression Rating Scale) consists of 17 items, some scored on a 5-point scale (0-4) and others scored on a 3-point scale (0-2). Items from the scale can be summed to give a total score ranging from 0 to 50, with higher scores indicating a worse outcome. This analysis is based on a single item from the scale (Self Harm, measured on a 5-point scale) where a higher score again indicates a worse outcome. |
Countries
United States
Participant flow
Pre-assignment details
1 participant consented to the study, but decided not to continue before completing screening measures due to scheduling difficulties.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants received Prazosin (1mg capsule) and Placebo during the course of the research study. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight (kg) | 60.6 Weight in (kg) STANDARD_DEVIATION 10.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire
The individual question about frightening dreams from the Nightmares Subscale of a self-administered questionnaire (Sleep-50 Questionnaire), will be used to determine if there is a decrease in frequency of nightmares in patients undergoing drug intervention. For each question, respondents are provided with a scale ranging from 1 (not at all) to 4 (very much) and are asked to indicate the extent to which the statement has matched their experience over the study time frame. The scale values range from 1-4, where a lower value indicates lower frequency of nightmares. A higher score is a worse outcome.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prazosin | Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire | 2.25 score on a scale | Standard Error 0.37 |
| Placebo | Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire | 2.75 score on a scale | Standard Error 0.25 |
Primary
Decrease in Rapid Eye Movement (REM) Density & Normalization of REM Disruptions
PSG (Polysomnogram) will be used in 2 participants to determine if there is a decrease in REM density in patients undergoing drug intervention.
Time frame: 3 weeks
Population: This study was designed to include a second phase involving polysomnography in 2 participants if there was enough signal efficacy found based on subjective measures. The second phase was not done, therefore no data was analyzed for this outcome measure.
Secondary
Decrease in Bulimia Symptoms
EDI-3 (Eating Disorder Inventory 3 Scale) is a pencil and paper test consisting of 91 items and 12 sub-scales. The main scales are the drive for thinness and the bulimia scales, the remaining sub-scales are: low self-esteem, body dissatisfaction, maturity fears, personal alienation, interpersonal alienation, interpersonal insecurity, perfectionism, interoceptive deficits, emotional dysregulation, and asceticism. The response options are based on a 6-point Likert-type scale are: Always, Usually, Often, Sometimes, Rarely, and Never. There are six composite scores, 12 primary scores, and three response style validity indicators. Software is used to calculate the raw scores, composite scores, validity scale scores and the T-scores. The t-score for the Bulimia scale will be used for this analysis with a range of 22-66. Higher scores indicate the likelihood of an eating disorder. A higher t-score on the bulimia scale indicates a worse outcome.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prazosin | Decrease in Bulimia Symptoms | 43.1 T-Score | Standard Error 5 |
| Placebo | Decrease in Bulimia Symptoms | 38.6 T-Score | Standard Error 4.8 |
Secondary
Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview
Rating scales and subject interview will be used to determine if there is a decrease in depressed mood among participants undergoing drug intervention. The HDRS (Hamilton Depression Rating Scale) consists of 17 items, some scored on a 5-point scale (0-4) and others scored on a 3-point scale (0-2). Items from the scale can be summed to give a total score ranging from 0 to 50, with higher scores indicating a worse outcome. This analysis is based on a single item from the scale (Depressed Mood, measured on a 5-point scale) where a higher score again indicates a worse outcome.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prazosin | Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview | 1.4 score on a scale | Standard Error 0.4 |
| Placebo | Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview | 1.3 score on a scale | Standard Error 0.5 |
Secondary
Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview
Rating scales and subject interview will be used to determine if there is a decrease in self harm among participants undergoing drug intervention. The HDRS (Hamilton Depression Rating Scale) consists of 17 items, some scored on a 5-point scale (0-4) and others scored on a 3-point scale (0-2). Items from the scale can be summed to give a total score ranging from 0 to 50, with higher scores indicating a worse outcome. This analysis is based on a single item from the scale (Self Harm, measured on a 5-point scale) where a higher score again indicates a worse outcome.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prazosin | Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview | 0.5 score on a scale | Standard Error 0.4 |
| Placebo | Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview | .1 score on a scale | Standard Error 0.1 |
Secondary
Decrease in Total CAPS Score (PTSD)
The CAPS (Clinician administered PTSD) rating scale consists of 30 questions rated on a 0-4 point scoring system and patient interview will be used to determine if there is a decrease in PTSD Symptoms among participants undergoing drug intervention. 17 of these questions are used to calculate the total severity score used in this analysis. This is done by summing the frequency and intensity ratings (each ranging from 0-4) for each of the 17 questions. The total severity score can have a range of 0-136. A higher score on this scale indicates a worse outcome.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prazosin | Decrease in Total CAPS Score (PTSD) | 65.5 score on a scale | Standard Error 9.1 |
| Placebo | Decrease in Total CAPS Score (PTSD) | 79.8 score on a scale | Standard Error 12.9 |