Posttraumatic Stress DisorderNCT00890643
Effect of Prazosin on Neurophysiology and Cognition in Post-Traumatic Stress Disorder (PTSD)
A study testing prazosin hydrochloride in people with Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
In this study, the investigators are looking at how PTSD affects things such as memory, attention, reaction to sounds, eye movements, and heart rate. The investigators are also studying whether a medication called prazosin has an effect on these things. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- prazosin hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exposure to one or more life-threatening war zone trauma events;
- DSM-IV diagnosis of PTSD derived from the Clinician-Administered PTSD Scale (CAPS), CAPS total score greater than or equal to 50;
- CAPS recurrent distressing dreams item score greater than or equal to 5 (of a maximum score of 8), with a frequency rating greater than or equal to 2 (of 4);
- stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization;
- good general medical health;
- female participants must agree to use a reliable form of birth control throughout study.
Who cannot join
- Acute or unstable chronic medical illness;
- diagnosis of current schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified, bipolar disorder, delirium, or cognitive disorder;
- severe psychiatric instability or severe situational life crises;
- substance dependence disorder currently or in past 3 months;
- current cocaine or stimulant abuse or evidence of acute intoxication on alcohol or nonprescribed medication;
- allergy or previous adverse reaction to prazosin or other alpha-1 adrenergic antagonists;
Show all 13Show fewer
- serious head injury with loss of consciousness of greater than 30 minutes;
- current diagnosis of seizure disorder;
- current use of prazosin or other alpha-1 adrenergic antagonists;
- current use of atypical antipsychotic medication;
- stimulants or alternative medications with stimulant properties (e.g. ephedra), certain exposure therapies must be completed at least 4 weeks before baseline;
- certain medications (trazodone, erectile disfunction medications) are not allowed or are restricted during the study;
- women must not be pregnant or nursing during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98109
About this study
Official title: Effect of Prazosin on Neurophysiologic Responses and Cognitive Performance in PTSD
In this study, the investigators are looking at how PTSD affects things such as memory, attention, reaction to sounds, eye movements, and heart rate. The investigators are also studying whether a medication called prazosin has an effect on these things.
Read the detailed description
Converging lines of evidence suggest that central nor adrenergic function is perturbed in PTSD. Placebo-controlled trials demonstrate that the centrally acting alpha-1 antagonist prazosin is clinically effective for several core symptoms of PTSD in combat veterans. However, no detailed assessment of the impact of prazosin on human neurophysiology and cognition have been conducted. Our hypotheses are based on studies that demonstrate (1) the importance of central adrenergic receptors in regulating fundamental neurophysiologic and cognitive functions, (2) the alteration of these functions in PTSD, and (3) the efficacy of prazosin in improving the clinical symptoms of PTSD. The primary objective of this study is to measure the subtle neurocognitive and neurophysiologic effects on prazosin in combat veterans with PTSD.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- prazosin hydrochloride, placebo
- Keywords
- Stress disorders, post-traumatic, Combat Disorders, prazosin, cognition, neurophysiology
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prazosin hydrochlorideDrug
Also called Minipress
prazosin 1-20 mg/day in divided doses
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Persons with PTSD Receives: Drug: prazosin hydrochloride |
| Arm 2 | Placebo comparator | Persons with PTSD Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responses to acoustic startle and prepulse inhibition of acoustic startle
Measured: baseline, week 2, week 8
Secondary outcomes (2)
Heart rate variability
Measured: baseline, week 2, week 8
Pennsylvania Computerized Neurocognitive Battery (CNB)
Measured: baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionSep 2011
Why it stopped: Primary investigator left VA employment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dorcas J. Dobie, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890643
- Sponsor's protocol ID
- MHBA-018-08S
- Status last verified
- Sep 2013
- First submitted
- 28 Apr 2009
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prazosin on Neurophysiologic Responses and Cognitive Performance in PTSD
- ClinicalTrials.gov ID
- NCT00890643
- Acronym / sponsor ID
- MHBA-018-08S
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Stress disorders, post-traumatic, Combat Disorders, prazosin, cognition, neurophysiology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Primary investigator left VA employment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators are looking at how PTSD affects things such as memory, attention, reaction to sounds, eye movements, and heart rate. The investigators are also studying whether a medication called prazosin has an effect on these things.
Detailed description
Converging lines of evidence suggest that central nor adrenergic function is perturbed in PTSD. Placebo-controlled trials demonstrate that the centrally acting alpha-1 antagonist prazosin is clinically effective for several core symptoms of PTSD in combat veterans. However, no detailed assessment of the impact of prazosin on human neurophysiology and cognition have been conducted. Our hypotheses are based on studies that demonstrate (1) the importance of central adrenergic receptors in regulating fundamental neurophysiologic and cognitive functions, (2) the alteration of these functions in PTSD, and (3) the efficacy of prazosin in improving the clinical symptoms of PTSD. The primary objective of this study is to measure the subtle neurocognitive and neurophysiologic effects on prazosin in combat veterans with PTSD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: prazosin hydrochloridePersons with PTSD |
| Arm 2 | Placebo comparator | Drug: placeboPersons with PTSD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Exposure to one or more life-threatening war zone trauma events;
- DSM-IV diagnosis of PTSD derived from the Clinician-Administered PTSD Scale (CAPS), CAPS total score greater than or equal to 50;
- CAPS recurrent distressing dreams item score greater than or equal to 5 (of a maximum score of 8), with a frequency rating greater than or equal to 2 (of 4);
- stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization;
- good general medical health;
Key exclusion criteria (13 listed)
- Acute or unstable chronic medical illness;
- diagnosis of current schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified, bipolar disorder, delirium, or cognitive disorder;
- severe psychiatric instability or severe situational life crises;
- substance dependence disorder currently or in past 3 months;
- current cocaine or stimulant abuse or evidence of acute intoxication on alcohol or nonprescribed medication;
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 |
|---|---|---|
| prazosin hydrochlorideAlso: Minipressprazosin 1-20 mg/day in divided doses | Drug | Arm 1 |
| placeboplacebo | Drug | Arm 2 |
Primary outcome
Responses to acoustic startle and prepulse inhibition of acoustic startle
Time frame: baseline, week 2, week 8
2 secondary outcomes
Heart rate variability
Time frame: baseline, week 2, week 8
Pennsylvania Computerized Neurocognitive Battery (CNB)
Time frame: baseline, week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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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.
Dorcas J. Dobie, MD principal investigator
VA Puget Sound Health Care System
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 hydrochloride in people with Posttraumatic Stress Disorder, run by US Department of Veterans Affairs 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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 23 Sep 2013. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Responses to acoustic startle and prepulse inhibition of acoustic startle (time frame: baseline, week 2, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2013.