Effect of Prazosin on Neurophysiology and Cognition in Post-Traumatic Stress Disorder (PTSD)

Posttraumatic Stress Disorder Clinical Trial

Official title:

Effect of Prazosin on Neurophysiologic Responses and Cognitive Performance in PTSD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00890643
• Other study ID #: MHBA-018-08S
• Status: Withdrawn
• Phase: N/A
• First received: April 28, 2009
• Last updated: September 20, 2013
• Start date: December 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• prazosin hydrochloride
prazosin 1-20 mg/day in divided doses
• placebo
placebo

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responses to acoustic startle and prepulse inhibition of acoustic startle		baseline, week 2, week 8	No
Secondary	Heart rate variability		baseline, week 2, week 8	No
Secondary	Pennsylvania Computerized Neurocognitive Battery (CNB)		baseline, week 8	No