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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 3, 2001 |
| Last Updated Date | January 20, 2009 |
| Start Date ICMJE | November 1999 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00018603 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Guanfacine for the Treatment of Post Traumatic Stress Disorder (PTSD) |
| Official Title ICMJE | Guanfacine for the Treatment of PTSD |
| Brief Summary | This is a double-blind, placebo-controlled, randomized study lasting 8 weeks. Purpose of the study is two-fold: first, to use a pharmacological agent to treat symptoms of PTSD, and second, to explore neurobiological mechanisms of action of guanfacine. |
| Detailed Description | Subject population is comprised of 100 persons with PTSD. 50 patients will receive guanfacine and 50 patients will receive a placebo. Guanfacine is prescribed at 1 mg/day and may be increased to 2 mg/day. Samples of plasma MHPG will be collected weekly. Clinical ratings of PTSD anxiety and depression, as well as vital signs, will be assessed weekly. Repeated measures analysis of variance will assess significance of main effect of drug, time, and drug by time. |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE | Post-Traumatic Stress Disorder |
| Intervention ICMJE | Drug: guanfacine |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | October 2002 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
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| Gender | Both |
| Ages | 18 Years to 65 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00018603 |
| Responsible Party | |
| Study ID Numbers ICMJE | MHBS-047-99F |
| Study Sponsor ICMJE | Department of Veterans Affairs |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Department of Veterans Affairs |
| Verification Date | December 2004 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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