Clinical trial NCT02382848: Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD
Official title: Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Bulimia Nervosa
Keywords: Eating Disorders
Bulimia Nervosa
Nightmares
Post Traumatic Stress Disorder
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire
timeFrame: 3 weeks
measure: Decrease in Rapid Eye Movement (REM) Density & Normalization of REM Disruptions
timeFrame: 3 weeks
Secondary outcomes:
measure: Decrease in Bulimia Symptoms
timeFrame: 3 weeks
measure: Decrease in Total CAPS Score (PTSD)
timeFrame: 3 weeks
measure: Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview
timeFrame: 3 weeks
measure: Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine, Milton S. Hershey Medical Center
name: Fauzia Mahr
role: PRINCIPAL_INVESTIGATOR
References:
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