Venlafaxine ER long-term extension study for major depressive disorder

An open-label long-term extension study to evaluate the safety and efficacy of venlafaxine ER in adult outpatients with major depressive disorder(B2411264)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221669

Enrollment

Registered

2011-12-08

Start date

2011-12-08

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

Major depressive disorder

Interventions

investigational material(s) Generic name etc : venlafaxine ER 75 mg/day to 225 mg/day INN of investigational material : venlafaxine ER Therapeutic category code : 117 Psychotropic agents Dosage and Ad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Outpatients who have completed 8 weeks double-blind study (B2411263), without major protocol violations or tolerability concerns in the opinion of the investigator.

Exclusion criteria

Exclusion criteria: -Clinically important abnormalities on baseline (Week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week 8 in the previous double-blind study. -Significant risk of suicide based on clinical judgment. -Use of prohibited treatments

Design outcomes

Primary

Measure	Time frame
Safety and tolerability Month 10	—

Secondary

Measure	Time frame
-Hamilton Rating Scale for Depression, 17 items (HAM-D17) total score -Clinical Global Impression-Severity (CGI-S) -Quick Inventory of Depressive Symptomatology-Self Report, 16 items (QIDS16-SR-J) total score -Clinical Global Impression-Improvement (CGI-I) Month 10	—

Outcome results

None listed

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