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BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

Primary Purpose

Post-Traumatic Stress Disorder

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Paroxetine

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Paroxetine

Arm Description

A 52-week, non-comparative, uncontrolled study (However, the baseline phase is single blind)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of responders based on the CGI Global Improvement

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

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

Change from baseline in the CAPS-SX hyperarousal cluster score

Change from baseline in the CGI Severity of Illness score

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

Full Information

NCT ID

NCT00839397

First Posted

January 29, 2009

Last Updated

March 6, 2014

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00839397

Brief Title

BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

Official Title

BRL29060A in Posttraumatic Stress Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

May 2002 (undefined)

Primary Completion Date

November 2004 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paroxetine

Arm Type

Other

Arm Description

A 52-week, non-comparative, uncontrolled study (However, the baseline phase is single blind)

Intervention Type

Drug

Intervention Name(s)

Paroxetine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Proportion of responders based on the CGI Global Improvement

Time Frame

52 weeks

Title

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

Time Frame

52 weeks

Title

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

Time Frame

52 weeks

Title

Change from baseline in the CAPS-SX hyperarousal cluster score

Time Frame

52 weeks

Title

Change from baseline in the CGI Severity of Illness score

Time Frame

52 weeks

Title

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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%.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

19068000

Citation

Kim Y, Asukai N, Konishi T, Kato H, Hirotsune H, Maeda M, Inoue H, Narita H, Iwasaki M. Clinical evaluation of paroxetine in post-traumatic stress disorder (PTSD): 52-week, non-comparative open-label study for clinical use experience. Psychiatry Clin Neurosci. 2008 Dec;62(6):646-52. doi: 10.1111/j.1440-1819.2008.01862.x.

Results Reference

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BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

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