Combination Of PAXIL Tablet And Benzodiazepines

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Mental Disorders

Treatments: Drug: paroxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259883

104228

Details and patient eligibility

About

This study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D).

Enrollment: 150 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with depression or depressive episodes who are diagnosed to have major depressive disorders according to the DSM-IV criteria.
• Patients with 14 or higher points in total scores for Items No.1 - 17 on HAM-D.
• Patients who have continuously received Benzodiazepine anxiolytics.

Exclusion criteria

• Patients with a strong suicide tendency.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

paroxetine

Experimental group

Description:

paroxetine 20 to 40mg/day

Treatment:

Drug: paroxetine