Long-term extension study to evaluate safety and efficacy of Venlafaxine in participants with generalized anxiety disorder who completed the J-GATE study

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(J-GATE)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220234

Enrollment

132

Registered

2022-07-31

Start date

2022-11-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GENERALIZED ANXIETY DISORDER

Interventions

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 week

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
The primary endpoints will be the safety endpoints. All safety analyses will be performed on the Safety Set.	—

Contacts

Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K.

IQVIA Services Japan G.K

Viatris_GAD_CL@iqvia.com+81-3-6859-9500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026