Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01485887
First received: November 29, 2011
Last updated: May 1, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | April 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
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Japan | |
| Nippon Medical School Chiba Hokusoh Hospital | Recruiting |
| Inzai, Chiba, Japan | |
| Nakamoto Clinic | Recruiting |
| Noda City, Chiba, Japan | |
| Stress Care Yoshimura Clinic | Recruiting |
| Fukuoka-shi, Fukuoka, Japan | |
| Hatakeyama Clinic | Active, not recruiting |
| Kitakyushu, Fukuoka, Japan | |
| Shiranui Hospital | Recruiting |
| Omuta, Fukuoka, Japan | |
| Fujikawa Clinic | Recruiting |
| Hatsukaichi, Hiroshima, Japan | |
| Terauchi-Takahashi Psychiatric Clinic | Recruiting |
| Ashiya, Hyogo, Japan | |
| Ikeuchi Psycho Induced Internal Med.Clinic | Recruiting |
| Kobe, Hyogo, Japan | |
| National Hospital Organization Kanazawa Medical Center | Recruiting |
| Kanazawa, Ishikawa, Japan | |
| Medical Corporation Seishinkai Kishiro Mental Clinic | Recruiting |
| Kawasaki, Kanagawa, Japan | |
| Yutaka Clinic | Recruiting |
| Sagamihara, Kanagawa, Japan | |
| Tawara Clinic | Completed |
| Yokohama, Kanagawa, Japan | |
| Shioiri Mental Clinic | Recruiting |
| Yokosuka city, Kanagawa, Japan | |
| Kuginuki Clinic | Not yet recruiting |
| Hirakata, Osaka, Japan | |
| Shibamoto Clinic | Recruiting |
| Osakasayama-shi, Osaka, Japan | |
| Suzuki Hospital | Recruiting |
| Adachi-ku, Tokyo, Japan | |
| Sangenjaya Nakamura Mental Clinic | Recruiting |
| Setagaya-ku, Tokyo, Japan | |
| Maynds Tower Mental Clinic | Recruiting |
| Shibuya-ku, Tokyo, Japan | |
| Himeno Tomomi Clinic | Not yet recruiting |
| Shinagawa-Ku, Tokyo, Japan | |
| Tokyo Kosei Nenkin Hospital | Recruiting |
| Shinjuku-ku, Tokyo, Japan | |
| Himorogi Psychiatric Institute | Recruiting |
| Toshima-ku, Tokyo, Japan | |
| Stress Care Yoshimura Clinic | Recruiting |
| Fukuoka, Japan | |
| Kuranari Psychiatry Clinic | Recruiting |
| Fukuoka, Japan | |
| Tenjin Mental Clinic | Recruiting |
| Fukuoka, Japan | |
| Medical Corporation Toyokokai Tawara Clinic | Completed |
| Kanagawa, Japan | |
| Sagaarashiyama-Tanaka Clinic | Recruiting |
| Kyoto, Japan | |
| Misato Ekimae Clinic | Not yet recruiting |
| Saitama, Japan | |
| Omotesando Mental Clinic 9F Success Aoyama | Recruiting |
| Tokyo, 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: | May 1, 2013 |
| 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 May 16, 2013