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Venlafaxine ER Phase 3 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 75 mg/day (fixed dose) (Drug); venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) (Drug); Placebo (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


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.

Clinical Details

Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination

Secondary outcome:

Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination

Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination

Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination

Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination

Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Akasaka Kato Clinic, Fukuoka 8100041, Japan

Ange Psychiatric Clinic, Fukuoka 810-0035, Japan

Hiro Mental Clinic Tenjinminami, Fukuoka 810-0004, Japan

Imato Clinic, Fukuoka 815-0041, Japan

Kuranari Psychiatry Clinic, Fukuoka 810-0801, Japan

Medical Corporation Shinseikai Kaku Mental Clinic, Fukuoka 810-0022, Japan

Stress Care Yoshimura Clinic, Fukuoka 810-0041, Japan

Sugahara Tenjin Clinic, Fukuoka 810-0001, Japan

Tenjin Mental Clinic, Fukuoka 810-0004, Japan

Tsuji Mental Clinic, Hiroshima 731-0112, Japan

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

Sagaarashiyama-Tanaka Clinic, Kyoto 616-8421, Japan

Kyo Mental Clinic, Nara 631-0036, Japan

JIN clinic, Osaka 530-0041, Japan

Misato Ekimae Clinic, Saitama 341-0018, Japan

Eto Mental Clinic Meguro, Tokyo 142-0021, Japan

Mizuho Clinic, Nagoya, Aichi 467-0806, Japan

Narumi Himawari Clinic, Nagoya, Aichi 458-0801, Japan

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

Hida Clinic, Nagareyama, Chiba 270-0163, Japan

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

Hatsuki Shinryo Clinic, Fukuoka-city, Fukuoka 814-0104, Japan

Hatakeyama Clinic, Kitakyushu-shi, Fukuoka 802-0064, Japan

Oka Clinic, Omuta-city, Fukuoka 836-0044, Japan

Shiranui Hospital, Omuta, Fukuoka 836-0004, Japan

Fujikawa Clinic, Hatsukaichi, Hiroshima 738-0023, Japan

Hayakawa Clinic, Kure, Hiroshima 737-0111, Japan

Kawamura Mental Clinic, Sapporo, Hokkaido 001-0023, Japan

Maruyamapark Mentalclinic, Sapporo, Hokkaido 064-0820, Japan

Arai Clinic, Amagasaki, Hyogo 660-0882, Japan

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

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

Tatsuta Clinic, Kobe, Hyogo 651-0097, 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, Kanagawa 252-0303, Japan

Azamino Mental Clinic, Yokohama-Shi, Kanagawa 225-0011, Japan

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

Yuge Hospital, Kumamoto-shi, Kumamoto 861-8002, Japan

Kuginuki Clinic, Hirakata, Osaka 573-0032, Japan

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

Sakai Mental Clinic, Saitama-city, Saitama 330-0062, Japan

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

Iidabashi Mental Clinic, Chiyoda-ku, Tokyo 102-0071, Japan

Tutujigaoka Mental Clinic, Chofu, Tokyo 182-0006, Japan

Fuku Clinic, Katsushika-ku, Tokyo 125-0041, Japan

Akasaka Clinic, Minato-ku, Tokyo 107-0052, Japan

SAKURAZAKA CLINIC SophyAnce, Minato-ku, Tokyo 106-0032, Japan

Harikae mental clinic, Nakano-Ku, Tokyo 164-0001, Japan

Heartcare Ginga Clinic, Nakano-ku, Tokyo 164-0012, Japan

Komazawa Mental Clinic, Setagaya-ku, Tokyo 154-0012, 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

Yoyoginomori Mental Clinic, Shibuyaku, Tokyo 151-0053, Japan

Himeno Tomomi Clinic, Shinagawa-Ku, Tokyo 141-0032, Japan

Meguro sta.East Mental Clinic, Shinagawa-ku, Tokyo 141-0021, Japan

Kagurazaka Stress Clinic, Shinjuku-ku, Tokyo 162-0825, Japan

Nishi-Shinjuku Concieria Clinic, Shinjuku-ku, Tokyo 160-0023, Japan

Tamaki Clinic, Shinjuku-ku, Tokyo 160-0023, Japan

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

Tokyo Women's Medical University Hospital, Shinjuku-ku, Tokyo 162-8666, 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: November 2011
Last updated: March 2, 2015

Page last updated: August 23, 2015

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