Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)

NCT ID: NCT01441440

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-03-31

Brief Summary

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), compared to placebo. This study consists of 2 week screening phase, 8 week treatment phase and 2 week tapering phase. The follow-up visit will be evaluated after 2 weeks of last study medication dosing.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

venlafaxine ER 75 mg/day (fixed dose)

Group Type: EXPERIMENTAL

venlafaxine ER 75 mg/day (fixed dose)

Intervention Type: DRUG

Treatment phase: 8 weeks (37.5 mg/day for 1st week and 75 mg/day for 7 weeks), oral administration Tapering phase: 2 weeks (37.5 mg/day for the 1st week and placebo for the 2nd week), oral administration

venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)

Group Type: EXPERIMENTAL

venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)

Intervention Type: DRUG

Treatment phase: 8 weeks (37.5 mg/day for the 1st week, 75 mg/day for the 2nd weeks, 75-150 mg for the 3rd week, 75-225 mg/day for the rest of 5 weeks), oral administration Tapering phase: 2 weeks (75/37.5 mg/day for the 1st week and 37.5 mg/day/placebo for the 2nd week), oral administration

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration

Interventions

venlafaxine ER 75 mg/day (fixed dose)

Treatment phase: 8 weeks (37.5 mg/day for 1st week and 75 mg/day for 7 weeks), oral administration Tapering phase: 2 weeks (37.5 mg/day for the 1st week and placebo for the 2nd week), oral administration

Intervention Type: DRUG

venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)

Treatment phase: 8 weeks (37.5 mg/day for the 1st week, 75 mg/day for the 2nd weeks, 75-150 mg for the 3rd week, 75-225 mg/day for the rest of 5 weeks), oral administration Tapering phase: 2 weeks (75/37.5 mg/day for the 1st week and 37.5 mg/day/placebo for the 2nd week), oral administration

Intervention Type: DRUG

Placebo

Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Outpatient status.
• A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
• Depressive symptoms for at least 90 days in single episode and for at least 28 days in recurrent episode before the screening visit.
• A MADRS total score ≥26 at the screening and baseline visits. And change of MADRS total score at baseline is not over 25% from the screening visit.
• A QIDS16-J-SR score ≥16 at the screening and baseline visits.
• A score ≥4 on the Clinical Global Impressions Scale-Severity (CGI-S) at the screening and baseline visits.

Exclusion Criteria

• Subjects who concurrently have Axis II personality disorder or mental retardation according to DSM-IV diagnostic criteria.
• Subjects who meet DSM-IV criteria for current or past history of Schizophrenia, Paranoid Disorders, or any other Psychotic Disorders.
• Subjects who meet DSM-IV criteria for current or past history of Dementia.
• Subjects who meet DSM-IV criteria for current or past history of bipolar disorder, Posttraumatic Stress Disorder (PTSD) or Obsessive Compulsive Disorder (OCD).
• Subjects who meet DSM-IV criteria for current (within 12 months before the screening visit) generalized anxiety disorder, panic disorder, or social anxiety disorder considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD).
• Subjects with a first degree relative with bipolar disorder.
• Subjects who are actively suicidal.
• History of non-responsive to 2 antidepressant treatment (at least 6-week usage for each) for the past or current episodes.
• History of Electroconvulsive therapy (ECT) at any time in the past.
• History of chronic treatment with benzodiazepines for longer than 6 months before the screening visit (Excluding subjects who have taken PRN benzodiazepine use, < 3 times/week).
• Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study.
• Known presence of raised intraocular pressure or history or presence of narrow angle glaucoma.
• Myocardial infarction within 180 days of the screening visit.
• Clinically important abnormalities, as determined by the investigator, on screening physical examination, electrocardiogram (ECG) or laboratory tests.
• Use of prohibited treatments

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Narumi Himawari Clinic

Nagoya, Aichi-ken, Japan

Mizuho Clinic

Nagoya, Aichi-ken, Japan

Nippon Medical School Chiba Hokusoh Hospital

Inzai, Chiba, Japan

Hida Clinic

Nagareyama, Chiba, Japan

Nakamoto Clinic

Noda, Chiba, Japan

Hatsuki Shinryo Clinic

Fukuoka, Fukuoka, Japan

Hatakeyama Clinic

Kitakyushu-shi, Fukuoka, Japan

Shiranui Hospital

Omuta, Fukuoka, Japan

Oka Clinic

Omuta, Fukuoka, Japan

Fujikawa Clinic

Hatsukaichi, Hiroshima, Japan

Hayakawa Clinic

Kure, Hiroshima, Japan

Kawamura Mental Clinic

Sapporo, Hokkaido, Japan

Maruyamapark Mentalclinic

Sapporo, Hokkaido, Japan

Arai Clinic

Amagasaki, Hyōgo, Japan

Takahashi Psychiatric Clinic

Ashiya, Hyōgo, Japan

Tatsuta Clinic

Kobe, Hyōgo, Japan

Ikeuchi Psycho Induced Internal Med.Clinic

Kobe, Hyōgo, Japan

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, Japan

Medical Corporation Seishinkai Kishiro Mental Clinic

Kawasaki, Kanagawa, Japan

Yutaka Clinic

Sagamihara, Kanagawa, Japan

Azamino Mental Clinic

Yokohama, Kanagawa, Japan

Shioiri Mental Clinic

Yokosuka, Kanagawa, Japan

Yuge Hospital

Kumamoto, Kumamoto, Japan

Kuginuki Clinic

Hirakata, Osaka, Japan

Shibamoto Clinic

Osakasayama-shi, Osaka, Japan

Sakai Mental Clinic

Saitama, Saitama, Japan

Suzuki Hospital

Adachi-ku, Tokyo, Japan

Iidabashi Mental Clinic

Chiyoda-ku, Tokyo, Japan

Tutujigaoka Mental Clinic

Chōfu, Tokyo, Japan

Fuku Clinic

Katsushika-ku, Tokyo, Japan

SAKURAZAKA CLINIC SophyAnce

Minato-ku, Tokyo, Japan

Akasaka Clinic

Minato-ku, Tokyo, Japan

Harikae mental clinic

Nakano-Ku, Tokyo, Japan

Heartcare Ginga Clinic

Nakano-ku, Tokyo, Japan

Sangenjaya Nakamura Mental Clinic

Setagaya-ku, Tokyo, Japan

Komazawa Mental Clinic

Setagaya-ku, Tokyo, Japan

Omotesando Mental Clinic

Shibuya-ku, Tokyo, Japan

Maynds Tower Mental Clinic

Shibuya-ku, Tokyo, Japan

Yoyoginomori Mental Clinic

Shibuyaku, Tokyo, Japan

Meguro sta.East Mental Clinic

Shinagawa-ku, Tokyo, Japan

Himeno Tomomi Clinic

Shinagawa-Ku, Tokyo, Japan

Nishi-Shinjuku Concieria Clinic

Shinjuku-ku, Tokyo, Japan

Tamaki Clinic

Shinjuku-ku, Tokyo, Japan

Kagurazaka Stress Clinic

Shinjuku-ku, Tokyo, Japan

Tokyo Kosei Nenkin Hospital

Shinjuku-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Himorogi Psychiatric Institute

Toshima-ku, Tokyo, Japan

Sugahara Tenjin Clinic

Fukuoka, , Japan

Hiro Mental Clinic Tenjinminami

Fukuoka, , Japan

Tenjin Mental Clinic

Fukuoka, , Japan

Medical Corporation Shinseikai Kaku Mental Clinic

Fukuoka, , Japan

Ange Psychiatric Clinic

Fukuoka, , Japan

Stress Care Yoshimura Clinic

Fukuoka, , Japan

Kuranari Psychiatry Clinic

Fukuoka, , Japan

Akasaka Kato Clinic

Fukuoka, , Japan

Imato Clinic

Fukuoka, , Japan

Tsuji Mental Clinic

Hiroshima, , Japan

Medical Corporation Toyokokai Tawara Clinic

Kanagawa, , Japan

Sagaarashiyama-Tanaka Clinic

Kyoto, , Japan

Kyo Mental Clinic

Nara, , Japan

JIN clinic

Osaka, , Japan

Misato Ekimae Clinic

Saitama, , Japan

Eto Mental Clinic Meguro

Tokyo, , Japan

Countries

Japan

References

Kato M, Asami Y, Wajsbrot DB, Wang X, Boucher M, Prieto R, Pappadopulos E. Clustering patients by depression symptoms to predict venlafaxine ER antidepressant efficacy: Individual patient data analysis. J Psychiatr Res. 2020 Oct;129:160-167. doi: 10.1016/j.jpsychires.2020.06.011. Epub 2020 Jul 9.

Reference Type: DERIVED

PMID: 32912597 (View on PubMed)

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

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2411263&StudyName=Venlafaxine%20ER%20Phase%203%20Study%20for%20Major%20Depressive%20Disorder%20%28MDD%29

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Other Identifiers

B2411263

Identifier Type: -

Identifier Source: org_study_id