Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy

NCT00121888 | Completed Phase 1

• 1 other identifier: 2002-P-001879
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the effectiveness and tolerability of controlled-release paroxetine (Paxil-CR) compared to placebo (an inactive substance) for individuals who continue to have symptoms of post traumatic stress disorder (PTSD) despite receiving prolonged exposure therapy.

Conditions

Stress Disorders, Post-Traumatic

Keywords

post traumatic stress disorder; Prolonged Exposure Therapy; pharmacotherapy; double-blind; Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• Symptoms of post traumatic stress disorder

Secondary Outcomes (1)

• Clinical global improvement

Interventions

Prolonged Exposure Therapy BEHAVIORAL

Paroxetine-CR DRUG

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) psychiatric diagnosis of PTSD as defined by DSM-IV criteria.
• Patients must have remained symptomatic (CGI-S \> 3) and a score of at least 6 on the Short PTSD Rating Interview (SPRINT) after a minimum of 7 sessions of PE (delivered within 6 weeks) to be eligible for randomized treatment.

You may not qualify if:

• Patients will be excluded from the study for serious medical illness or instability for which hospitalization may be likely within the next three months.
• Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded.
• Concurrent use of other psychotropic medications; all psychotropic medications (excluding benzodiazepines) must be stopped at least one week prior to entry into the initial PE phase of the study. Patients may remain on concomitant benzodiazepines (\<2 mg/d clonazepam or its equivalent), as long as the benzodiazepine therapy was initiated at least 2 months prior to randomization and at a constant dose for \>4 weeks prior to randomization; the dose will be held constant through the study.
• Patients with a history of hypersensitivity or poor response to paroxetine are excluded. Concurrent dynamic or supportive psychotherapy is permitted as long as it is has been ongoing for at least 2 months prior to onset of study entry.
• Patients with current compensation or legal actions related to the effects of the trauma, or those with an ongoing relationship with their assailant.
• Patients with a positive toxicology screen at baseline consistent with evidence of current substance abuse or dependence as determined by clinical interview.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• The Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Naomi M Simon, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2005
• First Posted: July 21, 2005
• Study Start: December 1, 2002
• Study Completion: June 1, 2007
• Last Updated: June 6, 2014

Record last verified: 2014-06

Locations

US (1)