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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02199652
Other study ID # 00001365
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2014
Est. completion date December 1, 2017

Study information

Verified date August 2018
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators hypothesize that patients receiving prazosin will have a greater reduction in suicidal ideation.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- PTSD

- Frequent nightmares

- Suicidality

Exclusion Criteria:

- Schizophrenia

- Bipolar

- Substance abuse

Study Design


Intervention

Drug:
Prazosin

Placebo


Locations

Country Name City State
United States Georgia Regents University Augusta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change Score for Scale for Suicide Ideation There will be data on the Scale for Suicide Ideation collected at the end of each week of treatment up to 8 weeks. Our apriori primary outcome is the change score in Scale for Suicide Ideation from baseline to the last observation.
This is a self report scale, with 19 items which measure present suicidality, each scored 0-2.
The total scale has a range from 0-38, with higher scores being worse
change score from baseline to last observation, up to 8 weeks
Secondary Disturbing Dreams and Nightmare Severity Index This is a self report scale, with 5 items, producing a total score with a range from 0-37. Higher scores are worse. A score greater than 10 is considered to indicate a clinically relevant problem with nightmares and/or bad dreams 8 weeks
Secondary Insomnia Severity Index This is a self report scale, with 7 items scored 0-4, producing a total score range 0-28.
Higher scores are worse Score 0-7 is interpreted as "no insomnia problem" 8-14 "subclinical insomnia" 15-21 "moderate insomnia" 22-28 "severe insomnia"
8 weeks
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