Stress Disorders, Post-TraumaticNCT02382848
Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD
A study testing Prazosin in people with Stress Disorders, Post-Traumatic and Bulimia Nervosa, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Bulimia Nervosa
- What is being tested?
- Prazosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 9 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45
- Clinical diagnosis of Bulimia Nervosa with complaint of nightmares secondary to PTSD
Who cannot join
- Restless leg syndrome
- Narcolepsy
- Sleep Apnea
- Neurological disorders
- Pregnancy
- cardiac abnormalities
Show all 9Show fewer
- significant electrolyte abnormalities
- Use of steroids, beta blockers, prazosin
- Alcohol/substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic, Bulimia Nervosa
- Being tested
- Prazosin, Placebo
- Keywords
- Eating Disorders, Bulimia Nervosa, Nightmares, Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrazosinDrug
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.
PlaceboDrug
Prazosin-matched placebo pill
PrazosinDrug
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.
PlaceboDrug
Prazosin-matched placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Prazosin, Then Placebo | Active comparator | 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 Receives: Drug: Prazosin; Drug: Placebo |
| Placebo, Then Prazosin | Placebo comparator | 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. Receives: Drug: Prazosin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Secondary outcomes (4)
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startJul 2015
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fauzia Mahr, MD, Milton S. Hershey Medical Center
- Investigators
- Fauzia Mahr, Principal investigator, Penn State College of Medicine, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382848
- Sponsor's protocol ID
- 00001746
- Status last verified
- Jun 2019
- First submitted
- 18 Feb 2015
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 20726290Singareddy 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.
PubMed 23623452Dansky 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.
PubMed 9097195Mitchell 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.
PubMed 22009722Gleaves 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.
PubMed 9697013Bicanic 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.
PubMed 22867760Vgontzas 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.
PubMed 9720852Lester 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.
PubMed 12537036Ross 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.
PubMed 8925274Taylor 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.
PubMed 17868655Germain 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.
PubMed 22281448
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prazosin in Bulimic Patients Experiencing Nightmares Due to PTSD
- ClinicalTrials.gov ID
- NCT02382848
- Acronym / sponsor ID
- 00001746
- Conditions
- Stress Disorders, Post-Traumatic, Bulimia Nervosa
- Keywords
- Eating Disorders, Bulimia Nervosa, Nightmares, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prazosin, Then Placebo | Active comparator | Drug: Prazosin, Drug: PlaceboParticipants 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 comparator | Drug: Prazosin, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-45
- Clinical diagnosis of Bulimia Nervosa with complaint of nightmares secondary to PTSD
Key exclusion criteria (9 listed)
- Restless leg syndrome
- Narcolepsy
- Sleep Apnea
- Neurological disorders
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrazosinA 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. | Drug | Prazosin, Then Placebo |
| PlaceboPrazosin-matched placebo pill | Drug | Prazosin, Then Placebo |
| PrazosinA 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. | Drug | Placebo, Then Prazosin |
| PlaceboPrazosin-matched placebo pill | Drug | Placebo, Then Prazosin |
Primary outcome
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.
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.
4 secondary outcomes
Decrease in Bulimia Symptoms
Time frame: 3 weeks
Decrease in Total CAPS Score (PTSD)
Time frame: 3 weeks
Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview
Time frame: 3 weeks
Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20726290Aurora 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.
- Background: PubMed 23623452Singareddy 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.
- Background: PubMed 9097195Dansky 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.
- Background: PubMed 22009722Mitchell 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.
- Background: PubMed 9697013Gleaves 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.
- Background: PubMed 22867760Bicanic 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.
- Background: PubMed 9720852Vgontzas 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.
- Background: PubMed 12537036Lester 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.
- Background: PubMed 8925274Ross 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.
- Background: PubMed 17868655Taylor 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.
- Background: PubMed 22281448Germain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fauzia Mahr principal investigator
Penn State College of Medicine, Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prazosin in people with Stress Disorders, Post-Traumatic and Bulimia Nervosa, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02382848, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.