Last updated: 11/04/2018 02:27:09

BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

GSK study ID
29060/799
See study documents
Clinicaltrials.gov ID
NCT00839397
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: BRL29060A in Posttraumatic Stress Disorder
Trial description: This was a 52-week, non-comparative, uncontrolled study of paroxetine in Japanese PTSD patients to obtain clinical experience regarding efficacy and safety. In this study, subjects received paroxetine 20mg–40mg once daily after an evening meal.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale One Week Symptom Status Version (CAPS-SX) total score

Timeframe: 52 weeks

Secondary outcomes:

Proportion of responders based on the CGI Global Improvement

Timeframe: 52 weeks

Change from baseline in the CAPS-SX re-experiencing cluster score

Timeframe: 52 weeks

Change from baseline in the CAPS-SX avoidance/numbing cluster score

Timeframe: 52 weeks

Change from baseline in the CAPS-SX hyperarousal cluster score

Timeframe: 52 weeks

Change from baseline in the CGI Severity of Illness score

Timeframe: 52 weeks

Adverse events (AEs), abnormal findings in each examination/test, and their details: Laboratory tests (hematology, clinical chemistry, electrolytes, urinalysis), Blood pressure, pulse rate, body weight

Timeframe: 52 weeks

Interventions:
  • Drug: Paroxetine
    • Enrollment:
    52
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Yoshiharu Kim, MD, PhD; Nozomu Asukai, MD, PhD; Takako Konishi, MD, PhD; Hiroshi Kato, MD, PhD; Hideto Hirotsune, MD; Masaharu Maeda, MD, PhD; Hirotaka Inoue, PhD; Hiroyasu Narita, PhD; and Masaru Iwasaki, MD, PhD. Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open- label study for clinical use experience. Psychiatry and Clinical Neurosciences 2008; 62: 646–652.
    Medical condition
    Post-Traumatic Stress Disorder
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    May 2002 to November 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Patients with a primary diagnosis of PTSD according to DSM-IV criteria (Posttraumatic Stress Disorder: 309.81). In order to diagnose PTSD, the Clinician-Administered PTSD Scale-DX Current and Lifetime Diagnostic Version (CAPS-DX) will be used.
    • Disease to Be Treated:
    • Exclusion Criteria at Week –1
    • Patients diagnosed with Axis I disorders (excluding PTSD) such as major depression, dysthymia, simple phobia, OCD, or panic disorder as a primary diagnosis according to DSM-IV criteria within 24 weeks prior to Week –1. However, patients with depressive disorders are allowed to enroll in the study, if PTSD was present before the depressive disorders appeared and PTSD is the predominant disorder.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with a primary diagnosis of PTSD according to DSM-IV criteria (Posttraumatic Stress Disorder: 309.81). In order to diagnose PTSD, the Clinician-Administered PTSD Scale-DX Current and Lifetime Diagnostic Version (CAPS-DX) will be used.
    • Disease to Be Treated:
    • Duration of illness of at least 3 months at Week –1.
    • Score >= 50 on Criteria B, C and D of CAPS-SX.
    • Age: >=18
    • <65 years (at the time of acquisition of informed consent)
    • Sex: No restriction
    • Hospitalization Status: No restriction
    • Informed consent: Gives his/her informed consent. In case of a subject who is under the age of 20, his/her parent/guardian must also give his/her written informed consent.
    Exclusion criteria:
    • Exclusion Criteria at Week –1
    • Patients diagnosed with Axis I disorders (excluding PTSD) such as major depression, dysthymia, simple phobia, OCD, or panic disorder as a primary diagnosis according to DSM-IV criteria within 24 weeks prior to Week –1. However, patients with depressive disorders are allowed to enroll in the study, if PTSD was present before the depressive disorders appeared and PTSD is the predominant disorder.
    • Patients presenting a current major depressive episode that preceded the diagnosis of PTSD. However, patients with depressive disorders are allowed to enroll in the study, if PTSD was present before the depressive disorders appeared and PTSD is the predominant disorder.
    • Patients receiving disability payments because of PTSD or any other psychiatric disorder.
    • Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
    • Patients taking St. Johns Wort.
    • Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) or substance dependence within 24 weeks prior to Week –1.
    • Patients who have attempted suicide within 24 weeks prior to Week –1 or who pose, in the investigator’s judgement using the M.I.N.I. “C. Suicidality”, a high suicidal risk.
    • Women who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study.
    • Patients who have taken MAO inhibitors within 1 week prior to Week –1 (or within 2 weeks prior to Week 0).
    • Patients who have had electroconvulsive therapy (ECT) within 12 weeks prior to Week –1.
    • Patients who have been treated with another investigational drug within 12 weeks prior to Week –1.
    • Patients with a history or complication of manic psychosis.
    • Patients with a history or complication of convulsive disorder (epilepsy, etc.).
    • Patients with a complication of glaucoma.
    • Patients with a known tendency for bleeding or those with predisposing conditions.
    • Patients with a history of hypersensitivity to paroxetine.
    • Patients with any serious organic disorder in the brain.
    • Patients with any serious physical symptom such as cardiac, hepatic, renal or hematopoietic dysfunction.
    • Patients with a history or complication of cancer or malignant tumor.
    • Others whom the investigator or sub-investigator considers ineligible for the study. Exclusion Criterion at Week 0
    • Patients whose placebo run-in medication compliance is less than 80%.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-19-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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