BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

May 31, 2002

Primary Completion Date

November 30, 2004

Study Completion Date

June 30, 2005

Conditions
Post-Traumatic Stress Disorder
Interventions
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"

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT00839397 - BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder | Biotech Hunter | Biotech Hunter