NCT00403455

Brief Summary

Dr. Wang's merit review is aimed at providing a better understanding of the relationship between SLC6A3/SLC6A4 and the mental health of veterans exposed to high levels of combat stress, specifically focusing on PTSD symptoms, related co-morbidities, treatment outcomes and seeks new approaches to therapy for our Veteran population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

December 8, 2014

Completed
Last Updated

July 2, 2018

Status Verified

May 1, 2018

Enrollment Period

4.8 years

First QC Date

November 22, 2006

Results QC Date

November 14, 2014

Last Update Submit

May 31, 2018

Conditions

PTSD

Keywords

ClinicalGeneticsMonoamine transporterPharmacogeneticsPost Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale (CAPS)

    The CAPS assessment is used to determine the severity of an individuals PTSD. The assessment examines Re-experiencing, Avoidance and Numbing, and Hyperarousal symptoms which total score in each of these categories are added together to achieve a total CAPS score. Scores on this assessment can range from 0-136 with 0 not having any PTSD symptoms and 136 having the most symptoms possible. The study uses this assessment at the baseline and at the end of treatment to determine the decrease in this score over the course of the study.

    12 weeks

Study Arms (1)

Paroxetine Arm

OTHER

This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.

Drug: Paroxetine

Interventions

ParoxetineDRUG

SSRI

Also known as: Paxil
Paroxetine Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S;
  • A minimum 6-month duration of PTSD illness; 3)CGI-S score of 4 or higher and a total CAPS-2 severity score of 50 or higher at the baseline visit;
  • Homozygous for either the S/S or L/L 5-HTT;
  • Females must not be pregnant or lactating and must agree to an acceptable form of contraception while receiving study medication and for 1 month after.

You may not qualify if:

  • Presence of any other primary axis I disorder (concurrent depression will be permitted if it is judged to be secondary to development for PTSD);
  • Suicide ideation or attempts within the past 3 months;
  • Alcohol or substance abuse or dependence in the past six months;
  • Evidence of clinically significant hepatic or renal disease;
  • Previous seizure disorder or condition predisposing to seizures, or on medications that might lower the seizure threshold
  • Any acute or unstable medical condition that might interfere with the safe conduct of the study;
  • Intolerance or hypersensitivity to citalopram or any other SSRI;
  • Treatment with a monoamine oxidase inhibitor within 14 days of initiating the study;
  • Concomitant treatment with serotonin agonists, other SSRIs, meperidine, tramadol or other medication as determined by the study clinician.
  • PTSD symptoms in need of immediate treatment as determined by clinical assessment from a psychiatrist not affiliated with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Zhewu Wang
Organization
Department of Veterans Affairs
Zhewu.Wang@va.gov
(843) 789-7949

Study Officials

  • Zhewu Wang, MD

    Ralph H. Johnson VA Medical Center, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

October 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 2, 2018

Results First Posted

December 8, 2014

Record last verified: 2018-05

Locations

US(1)