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.
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
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
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