BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

March 6, 2014 updated by: GlaxoSmithKline

BRL29060A in Posttraumatic Stress Disorder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Paroxetine
A 52-week, non-comparative, uncontrolled study (However, the baseline phase is single blind)
Drug: Paroxetine

Subjects will take the treatment phase medication once daily after an evening meal. All subjects will be maintained at Dose Level II (20 mg/day) for the first 2 weeks. If a sufficient clinical response ("1. Very much improved" or "2. Much improved" based on the CGI Global Improvement) is achieved, the subject will continue on the same dose level. When the clinical response is not sufficient but the investigational product is well tolerated, the dose will be increased to Dose Level III (30 mg/day) and then to Dose Level IV (40 mg/day) at intervals of at least 2 weeks until a sufficient response is reached. Once a sufficient response is obtained, the treatment will be continued at that dose. The treatment phase will last for a total of 52 weeks. In those patients receiving Dose Level III or IV, dosage reductions to the next lowest level (Dose Level II or III) consequent to an adverse event are permitted.

Dosage adjustment will be made at the discretion of the PI or Sub-PI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in the Clinician-Administered Posttraumatic Stress Disorder Scale One Week Symptom Status Version (CAPS-SX) total score
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of responders based on the CGI Global Improvement
Time Frame: 52 weeks
52 weeks
Change from baseline in the CAPS-SX re-experiencing cluster score
Time Frame: 52 weeks
52 weeks
Change from baseline in the CAPS-SX avoidance/numbing cluster score
Time Frame: 52 weeks
52 weeks
Change from baseline in the CAPS-SX hyperarousal cluster score
Time Frame: 52 weeks
52 weeks
Change from baseline in the CGI Severity of Illness score
Time Frame: 52 weeks
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
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29060/799

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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