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

NCT ID: NCT01485887

Last Updated: 2021-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Venlafaxine ER

Group Type EXPERIMENTAL

Venlafaxine ER

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Nippon Medical School Chiba Hokusoh Hospital

Inzai, Chiba, Japan

Site Status

Nakamoto Clinic

Noda, Chiba, Japan

Site Status

Stress Care Yoshimura Clinic

Fukuoka, Fukuoka, Japan

Site Status

Hatakeyama Clinic

Kitakyushu, Fukuoka, Japan

Site Status

Shiranui Hospital

Omuta, Fukuoka, Japan

Site Status

Fujikawa Clinic

Hatsukaichi, Hiroshima, Japan

Site Status

Takahashi Psychiatric Clinic

Ashiya, Hyōgo, Japan

Site Status

Ikeuchi Psycho Induced Internal Med.Clinic

Kobe, Hyōgo, Japan

Site Status

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, Japan

Site Status

Medical Corporation Seishinkai Kishiro Mental Clinic

Kawasaki, Kanagawa, Japan

Site Status

Yutaka Clinic

Sagamihara-shi, Kanagawa, Japan

Site Status

Tawara Clinic

Yokohama, Kanagawa, Japan

Site Status

Shioiri Mental Clinic

Yokosuka, Kanagawa, Japan

Site Status

Shibamoto Clinic

Osakasayama-shi, Osaka, Japan

Site Status

Suzuki Hospital

Adachi-ku, Tokyo, Japan

Site Status

Sangenjaya Nakamura Mental Clinic

Setagaya-ku, Tokyo, Japan

Site Status

Omotesando Mental Clinic

Shibuya-ku, Tokyo, Japan

Site Status

Maynds Tower Mental Clinic

Shibuya-ku, Tokyo, Japan

Site Status

Tokyo Kosei Nenkin Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

Himorogi Psychiatric Institute

Toshima-ku, Tokyo, Japan

Site Status

Tenjin Mental Clinic

Fukuoka, , Japan

Site Status

Stress Care Yoshimura Clinic

Fukuoka, , Japan

Site Status

Kuranari Psychiatry Clinic

Fukuoka, , Japan

Site Status

Medical Corporation Toyokokai Tawara Clinic

Kanagawa, , Japan

Site Status

Sagaarashiyama-Tanaka Clinic

Kyoto, , Japan

Site Status

Countries

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Japan

References

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Higuchi T, Kamijima K, Nakagome K, Itamura R, Asami Y, Kuribayashi K, Imaeda T. A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan. Int Clin Psychopharmacol. 2016 Jan;31(1):8-19. doi: 10.1097/YIC.0000000000000105.

Reference Type DERIVED
PMID: 26513202 (View on PubMed)

Related Links

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Other Identifiers

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B2411264

Identifier Type: -

Identifier Source: org_study_id

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