DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Venlafaxine ER (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

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

Summary

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.

Clinical Details

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 Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Clinical Significant Vital Changes

Number of Participants With Clinical Significant Laboratory Tests Changes

Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes

Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories

Secondary outcome:

Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point

Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point

Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point

Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point

Eligibility

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

Locations and Contacts

Kuranari Psychiatry Clinic, Fukuoka 810-0801, Japan

Stress Care Yoshimura Clinic, Fukuoka 810-0041, Japan

Tenjin Mental Clinic, Fukuoka 810-0004, Japan

Medical Corporation Toyokokai Tawara Clinic, Kanagawa 221-0835, Japan

Sagaarashiyama-Tanaka Clinic, Kyoto 616-8421, Japan

Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba 270-1694, Japan

Nakamoto Clinic, Noda City, Chiba 278-0033, Japan

Stress Care Yoshimura Clinic, Fukuoka-shi, Fukuoka 810-0041, Japan

Hatakeyama Clinic, Kitakyushu, Fukuoka 802-0064, Japan

Shiranui Hospital, Omuta, Fukuoka 836-0004, Japan

Fujikawa Clinic, Hatsukaichi, Hiroshima 738-0023, Japan

Takahashi Psychiatric Clinic, Ashiya, Hyogo 659-0093, Japan

Ikeuchi Psycho Induced Internal Med.Clinic, Kobe, Hyogo 655-0037, Japan

National Hospital Organization Kanazawa Medical Center, Kanazawa, Ishikawa 920-8650, Japan

Medical Corporation Seishinkai Kishiro Mental Clinic, Kawasaki, Kanagawa 214-0014, Japan

Yutaka Clinic, Sagamihara-shi, Kanagawa 252-0303, Japan

Tawara Clinic, Yokohama, Kanagawa 221-0835, Japan

Shioiri Mental Clinic, Yokosuka city, Kanagawa 238-0042, Japan

Shibamoto Clinic, Osakasayama-shi, Osaka 589-0011, Japan

Suzuki Hospital, Adachi-ku, Tokyo 120-0033, Japan

Sangenjaya Nakamura Mental Clinic, Setagaya-ku, Tokyo 154-0004, Japan

Maynds Tower Mental Clinic, Shibuya-ku, Tokyo 151-0053, Japan

Omotesando Mental Clinic, Shibuya-ku, Tokyo 150-0001, Japan

Tokyo Kosei Nenkin Hospital, Shinjuku-ku, Tokyo 162-8543, Japan

Himorogi Psychiatric Institute, Toshima-ku, Tokyo 170-0002, Japan

Additional Information

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

Starting date: January 2012
Last updated: May 13, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017