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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01485887
First received: November 29, 2011
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Venlafaxine ER
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
  • Number of Participants with clinical significant vital, laboratory tests, ECG changes [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
  • Number of Participants with suicidality risk [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hamilton Rating Scale for Depression, 17 items (HAM-D17) total score [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Severity (CGI-S) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Quick Inventory of Depressive Symptomatology-Self Report, 16 items (QIDS16-SR-J) [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venlafaxine ER Drug: Venlafaxine ER
Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485887

Locations
Japan
Nippon Medical School Chiba Hokusoh Hospital
Inzai, Chiba, Japan
Nakamoto Clinic
Noda City, Chiba, Japan
Stress Care Yoshimura Clinic
Fukuoka-shi, Fukuoka, Japan
Hatakeyama Clinic
Kitakyushu, Fukuoka, Japan
Shiranui Hospital
Omuta, Fukuoka, Japan
Fujikawa Clinic
Hatsukaichi, Hiroshima, Japan
Takahashi Psychiatric Clinic
Ashiya, Hyogo, Japan
Ikeuchi Psycho Induced Internal Med.Clinic
Kobe, Hyogo, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa, Japan
Medical Corporation Seishinkai Kishiro Mental Clinic
Kawasaki, Kanagawa, Japan
Yutaka Clinic
Sagamihara-shi, Kanagawa, Japan
Tawara Clinic
Yokohama, Kanagawa, Japan
Shioiri Mental Clinic
Yokosuka city, Kanagawa, Japan
Shibamoto Clinic
Osakasayama-shi, Osaka, Japan
Suzuki Hospital
Adachi-ku, Tokyo, Japan
Sangenjaya Nakamura Mental Clinic
Setagaya-ku, Tokyo, Japan
Omotesando Mental Clinic
Shibuya-ku, Tokyo, Japan
Maynds Tower Mental Clinic
Shibuya-ku, Tokyo, Japan
Tokyo Kosei Nenkin Hospital
Shinjuku-ku, Tokyo, Japan
Himorogi Psychiatric Institute
Toshima-ku, Tokyo, Japan
Tenjin Mental Clinic
Fukuoka, Japan
Kuranari Psychiatry Clinic
Fukuoka, Japan
Stress Care Yoshimura Clinic
Fukuoka, Japan
Medical Corporation Toyokokai Tawara Clinic
Kanagawa, Japan
Sagaarashiyama-Tanaka Clinic
Kyoto, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01485887     History of Changes
Other Study ID Numbers: B2411264
Study First Received: November 29, 2011
Last Updated: February 20, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Venlafaxine ER
long-term extension
Japan

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014