- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02382848
Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD
June 27, 2019 updated by: Fauzia Mahr, MD, Milton S. Hershey Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine, Milton S. Hershey Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Prazosin, Then 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
|
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.
Prazosin-matched placebo pill
A 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.
|
PLACEBO_COMPARATOR: Placebo, Then 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.
|
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.
Prazosin-matched placebo pill
A 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire
Time Frame: 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.
|
3 weeks
|
Decrease in Rapid Eye Movement (REM) Density & Normalization of REM Disruptions
Time Frame: 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.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in Bulimia Symptoms
Time Frame: 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.
|
3 weeks
|
Decrease in Total CAPS Score (PTSD)
Time Frame: 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.
|
3 weeks
|
Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview
Time Frame: 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.
|
3 weeks
|
Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview
Time Frame: 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.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fauzia Mahr, Penn State College of Medicine, Milton S. Hershey Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aurora RN, Zak RS, Auerbach SH, Casey KR, Chowdhuri S, Karippot A, Maganti RK, Ramar K, Kristo DA, Bista SR, Lamm CI, Morgenthaler TI; Standards of Practice Committee; American Academy of Sleep Medicine. Best practice guide for the treatment of nightmare disorder in adults. J Clin Sleep Med. 2010 Aug 15;6(4):389-401.
- Singareddy R, Krishnamurthy VB, Vgontzas AN, Fernandez-Mendoza J, Calhoun SL, Shaffer ML, Bixler EO. Subjective and objective sleep and self-harm behaviors in young children: a general population study. Psychiatry Res. 2013 Oct 30;209(3):549-53. doi: 10.1016/j.psychres.2013.03.036. Epub 2013 Apr 23.
- Dansky BS, Brewerton TD, Kilpatrick DG, O'Neil PM. The National Women's Study: relationship of victimization and posttraumatic stress disorder to bulimia nervosa. Int J Eat Disord. 1997 Apr;21(3):213-28. doi: 10.1002/(sici)1098-108x(199704)21:33.0.co;2-n.
- Mitchell KS, Mazzeo SE, Schlesinger MR, Brewerton TD, Smith BN. Comorbidity of partial and subthreshold ptsd among men and women with eating disorders in the national comorbidity survey-replication study. Int J Eat Disord. 2012 Apr;45(3):307-15. doi: 10.1002/eat.20965. Epub 2011 Oct 19.
- Gleaves DH, Eberenz KP, May MC. Scope and significance of posttraumatic symptomatology among women hospitalized for an eating disorder. Int J Eat Disord. 1998 Sep;24(2):147-56. doi: 10.1002/(sici)1098-108x(199809)24:23.0.co;2-e.
- Bicanic IA, Postma RM, Sinnema G, De Roos C, Olff M, Van Wesel F, Van de Putte EM. Salivary cortisol and dehydroepiandrosterone sulfate in adolescent rape victims with post traumatic stress disorder. Psychoneuroendocrinology. 2013 Mar;38(3):408-15. doi: 10.1016/j.psyneuen.2012.06.015. Epub 2012 Aug 4.
- Vgontzas AN, Tsigos C, Bixler EO, Stratakis CA, Zachman K, Kales A, Vela-Bueno A, Chrousos GP. Chronic insomnia and activity of the stress system: a preliminary study. J Psychosom Res. 1998 Jul;45(1):21-31. doi: 10.1016/s0022-3999(97)00302-4.
- Lester NA, Keel PK, Lipson SF. Symptom fluctuation in bulimia nervosa: relation to menstrual-cycle phase and cortisol levels. Psychol Med. 2003 Jan;33(1):51-60. doi: 10.1017/s0033291702006815.
- Ross RJ, Gresch PJ, Ball WA, Sanford LD, Morrison AR. REM sleep inhibition by desipramine: evidence for an alpha-1 adrenergic mechanism. Brain Res. 1995 Dec 1;701(1-2):129-34. doi: 10.1016/0006-8993(95)00984-x.
- Taylor FB, Martin P, Thompson C, Williams J, Mellman TA, Gross C, Peskind ER, Raskind MA. Prazosin effects on objective sleep measures and clinical symptoms in civilian trauma posttraumatic stress disorder: a placebo-controlled study. Biol Psychiatry. 2008 Mar 15;63(6):629-32. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.
- Germain A, Richardson R, Moul DE, Mammen O, Haas G, Forman SD, Rode N, Begley A, Nofzinger EA. Placebo-controlled comparison of prazosin and cognitive-behavioral treatments for sleep disturbances in US Military Veterans. J Psychosom Res. 2012 Feb;72(2):89-96. doi: 10.1016/j.jpsychores.2011.11.010. Epub 2011 Dec 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (ACTUAL)
March 9, 2018
Study Completion (ACTUAL)
March 9, 2018
Study Registration Dates
First Submitted
February 18, 2015
First Submitted That Met QC Criteria
March 6, 2015
First Posted (ESTIMATE)
March 9, 2015
Study Record Updates
Last Update Posted (ACTUAL)
July 16, 2019
Last Update Submitted That Met QC Criteria
June 27, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Feeding and Eating Disorders
- Trauma and Stressor Related Disorders
- Hyperphagia
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Bulimia
- Bulimia Nervosa
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Prazosin
Other Study ID Numbers
- 00001746
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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