Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD

Not Applicable

Completed

Conditions: Bulimia Nervosa
Stress Disorders, Post-Traumatic

Interventions: Drug: Prazosin
Drug: Placebo

Registration Number: NCT02382848

Lead Sponsor: Milton S. Hershey Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 9

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prazosin, Then Placebo	Placebo	Participants first received Prazosin. 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. After a washout period, they then receive Placebo
Placebo, Then Prazosin	Placebo	Participants first received Placebo (matching Prazosin) for a 3 consecutive week period during the 7 week study period. After a washout period, they then received Prazosin. The starting dose of Prazosin (1mg capsule) will be given at Week # 5 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.
Prazosin, Then Placebo	Prazosin	Participants first received Prazosin. 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. After a washout period, they then receive Placebo
Placebo, Then Prazosin	Prazosin	Participants first received Placebo (matching Prazosin) for a 3 consecutive week period during the 7 week study period. After a washout period, they then received Prazosin. The starting dose of Prazosin (1mg capsule) will be given at Week # 5 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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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 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.
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 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.