AN OPEN-LABEL, LONG-TERM EXTENSION, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VENLAFAXINE IN JAPANESE OUTPATIENTS WITH GENERALIZED ANXIETY DISORDER WHO COMPLETED STUDY B2411367

JRCT ID: jRCT2031220234

Registered date:31/07/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: GENERALIZED ANXIETY DISORDER
• Date of first enrollment: 08/11/2022
• Target sample size: 132
• Study type: Interventional

Intervention(s)

Venlafaxine will be administered once a day.

Treatment Period (52 weeks)
Participants will receive venlafaxine at each visit with reference to the dose escalation criteria.

Tapering Period (1-3 weeks)
Participants who have completed the treatment period will taper off their study intervention.
The tapering period may be reduced or omitted if the investigator determines that it should be shortened or omitted in order to change treatment urgently (eg, the treatment period of venlafaxine is short).

Outcome(s)

• Primary Outcome: The primary endpoints will be the safety endpoints. All safety analyses will be performed on the Safety Set.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: - Outpatient participants who have had no serious protocol deviation and completed 10 weeks of treatment including the tapering period, and who have had good tolerability to the study intervention, in the placebo-controlled double-blind comparative study of venlafaxine.
• Exclude criteria: - Participants who demonstrate any clinically significant abnormalities in physical examination at baseline (Week 10 visit of the double-blind comparative study), or participants who have not recovered from clinically significant abnormalities in ECG assessment, clinical laboratory tests, or vital signs recorded prior to Week 10 visit in the preceding double-blind comparative study.

Related Information

• Primary Sponsor: Kitano Madoka