Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)

Condition(s) targeted: Major Depressive Disorder

Intervention: Venlafaxine ER (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.

Official title: A Open-Label Long-Term Extension Study To Evaluate The Safety And Efficacy Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants with Adverse Events

Number of Participants with clinical significant vital, laboratory tests, ECG changes

Number of Participants with suicidality risk

Secondary outcome:

Hamilton Rating Scale for Depression, 17 items (HAM-D17) total score

Clinical Global Impression-Severity (CGI-S)

Clinical Global Impression-Improvement (CGI-I)

Quick Inventory of Depressive Symptomatology-Self Report, 16 items (QIDS16-SR-J)

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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:

- 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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Kuranari Psychiatry Clinic, Fukuoka, Japan; Recruiting

Stress Care Yoshimura Clinic, Fukuoka, Japan; Recruiting

Tenjin Mental Clinic, Fukuoka, Japan; Recruiting

Medical Corporation Toyokokai Tawara Clinic, Kanagawa, Japan; Recruiting

Sagaarashiyama-Tanaka Clinic, Kyoto, Japan; Recruiting

Misato Ekimae Clinic, Saitama, Japan; Not yet recruiting

Omotesando Mental Clinic 9F Success Aoyama, Tokyo, Japan; Recruiting

Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan; Recruiting

Nakamoto Clinic, Noda City, Chiba, Japan; Recruiting

Stress Care Yoshimura Clinic, Fukuoka-shi, Fukuoka, Japan; Recruiting

Hatakeyama Clinic, Kitakyushu, Fukuoka, Japan; Active, not recruiting

Shiranui Hospital, Omuta, Fukuoka, Japan; Recruiting

Fujikawa Clinic, Hatsukaichi, Hiroshima, Japan; Recruiting

Terauchi-Takahashi Psychiatric Clinic, Ashiya, Hyogo, Japan; Recruiting

Ikeuchi Psycho Induced Internal Med.Clinic, Kobe, Hyogo, Japan; Recruiting

National Hospital Organization Kanazawa Medical Center, Kanazawa, Ishikawa, Japan; Recruiting

Kishiro Mental Clinic, Kawasaki, Kanagawa, Japan; Recruiting

Yutaka Clinic, Sagamihara, Kanagawa, Japan; Recruiting

Tawara Clinic, Yokohama, Kanagawa, Japan; Recruiting

Shioiri Mental Clinic, Yokosuka city, Kanagawa, Japan; Recruiting

Kuginuki Clinic, Hirakata, Osaka, Japan; Not yet recruiting

Shibamoto Clinic, Osakasayama-shi, Osaka, Japan; Recruiting

Suzuki Hospital, Adachi-ku, Tokyo, Japan; Recruiting

Sangenjaya Nakamura Mental Clinic, Setagaya-ku, Tokyo, Japan; Recruiting

Maynds Tower Mental Clinic, Shibuya-ku, Tokyo, Japan; Recruiting

Himeno Tomomi Clinic, Shinagawa-Ku, Tokyo, Japan; Not yet recruiting

Tokyo Kosei Nenkin Hospital, Shinjuku-ku, Tokyo, Japan; Recruiting

Himorogi Psychiatric Institute, Toshima-ku, Tokyo, Japan; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: January 2012
Last updated: February 5, 2013