52
Participants
Start Date
May 31, 2002
Primary Completion Date
November 30, 2004
Study Completion Date
June 30, 2005
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"
Lead Sponsor
GlaxoSmithKline
INDUSTRY