A PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VENLAFAXINE IN JAPANESE OUTPATIENTS WITH GENERALIZED ANXIETY DISORDER

JRCT ID: jRCT2031220156

Registered date:22/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: GENERALIZED ANXIETY DISORDER
• Date of first enrollment: 15/08/2022
• Target sample size: 336
• Study type: Interventional

Intervention(s)

Treatment period (9 weeks): Participants will receive venlafaxine or placebo 37.5 mg/day - 225 mg/day depending on the dose escalation criteria. At some point during the administration period, all participants will be given a placebo for a week, but they will not be informed when they are taking the placebo.

Placebo Group:
Participants will receive a placebo for 9 weeks depending on the dose escalation criteria.
Venlafaxine Group:
Participants will receive venlafaxine 37.5 mg/day - 225 mg/day for 9 weeks depending on the dose escalation criteria.

Tapering period (2 weeks): Participants who have completed the treatment period will taper off their study intervention.

Outcome(s)

• Primary Outcome: The primary endpoint will be the change in the HAM-A total score from baseline to treatment completion or discontinuation.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participants with a diagnosis of GAD based on the DSM-5 diagnostic criteria, which is confirmed by the Mini International Neuropsychiatric Interview (MINI).
-Participants with a HAM-A total score >= 20 and CGI-S score >= 4 both at the initiation of the screening period and at baseline.
-Participants with a GAD-7 total score >= 10 both at the initiation of the screening period and at baseline.

Exclude criteria

-Participants with a Montgomery-Asberg Depression Rating Scale (MADRS) total score >= 20 at the initiation of the screening period or at baseline.
-Participants with an improvement of 20% or more on the HAM-A total score at baseline, compared with the score at the initiation of the placebo lead-in period.
-Participants with known hypersensitivity to venlafaxine or desvenlafaxine

Related Information

• Primary Sponsor: Kitano Madoka