Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT01441440
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 538
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description venlafaxine ER 75 mg/day (fixed dose) venlafaxine ER 75 mg/day (fixed dose) - venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination Baseline, Week 8 or Early termination HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
- Secondary Outcome Measures
Name Time Method Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination Baseline, Week 8 or Early termination MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 - 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination Baseline, Week 8 or Early termination CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination Baseline, Week 8 or Early termination HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
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 Baseline, Week 8 or Early termination QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.
Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination Baseline, Week 8 or Early termination CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.
Trial Locations
- Locations (63)
Tokyo Kosei Nenkin Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Akasaka Clinic
🇯🇵Minato-ku, Tokyo, Japan
Komazawa Mental Clinic
🇯🇵Setagaya-ku, Tokyo, Japan
Kagurazaka Stress Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Yoyoginomori Mental Clinic
🇯🇵Shibuyaku, Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Himorogi Psychiatric Institute
🇯🇵Toshima-ku, Tokyo, Japan
Nakamoto Clinic
🇯🇵Noda City, Chiba, Japan
Kuranari Psychiatry Clinic
🇯🇵Fukuoka, Japan
Imato Clinic
🇯🇵Fukuoka, Japan
Tsuji Mental Clinic
🇯🇵Hiroshima, Japan
Kyo Mental Clinic
🇯🇵Nara, Japan
Misato Ekimae Clinic
🇯🇵Saitama, Japan
Mizuho Clinic
🇯🇵Nagoya, Aichi, Japan
Kuginuki Clinic
🇯🇵Hirakata, Osaka, Japan
Sakai Mental Clinic
🇯🇵Saitama-city, Saitama, Japan
Hiro Mental Clinic Tenjinminami
🇯🇵Fukuoka, Japan
Tenjin Mental Clinic
🇯🇵Fukuoka, Japan
Hatsuki Shinryo Clinic
🇯🇵Fukuoka-city, Fukuoka, Japan
Hatakeyama Clinic
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Oka Clinic
🇯🇵Omuta-city, Fukuoka, Japan
Hida Clinic
🇯🇵Nagareyama, Chiba, Japan
Narumi Himawari Clinic
🇯🇵Nagoya, Aichi, Japan
Arai Clinic
🇯🇵Amagasaki, Hyogo, Japan
Nippon Medical School Chiba Hokusoh Hospital
🇯🇵Inzai, Chiba, Japan
Hayakawa Clinic
🇯🇵Kure, Hiroshima, Japan
Iidabashi Mental Clinic
🇯🇵Chiyoda-ku, Tokyo, Japan
Sangenjaya Nakamura Mental Clinic
🇯🇵Setagaya-ku, Tokyo, Japan
Shiranui Hospital
🇯🇵Omuta, Fukuoka, Japan
Fujikawa Clinic
🇯🇵Hatsukaichi, Hiroshima, Japan
Takahashi Psychiatric Clinic
🇯🇵Ashiya, Hyogo, Japan
Tatsuta Clinic
🇯🇵Kobe, Hyogo, Japan
Ikeuchi Psycho Induced Internal Med.Clinic
🇯🇵Kobe, Hyogo, Japan
Medical Corporation Seishinkai Kishiro Mental Clinic
🇯🇵Kawasaki, Kanagawa, Japan
Yutaka Clinic
🇯🇵Sagamihara, Kanagawa, Japan
Azamino Mental Clinic
🇯🇵Yokohama-Shi, Kanagawa, Japan
Shioiri Mental Clinic
🇯🇵Yokosuka city, Kanagawa, Japan
Yuge Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Suzuki Hospital
🇯🇵Adachi-ku, Tokyo, Japan
Fuku Clinic
🇯🇵Katsushika-ku, Tokyo, Japan
Tutujigaoka Mental Clinic
🇯🇵Chofu, Tokyo, Japan
Harikae mental clinic
🇯🇵Nakano-Ku, Tokyo, Japan
Heartcare Ginga Clinic
🇯🇵Nakano-ku, Tokyo, Japan
Maynds Tower Mental Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Medical Corporation Shinseikai Kaku Mental Clinic
🇯🇵Fukuoka, Japan
SAKURAZAKA CLINIC SophyAnce
🇯🇵Minato-ku, Tokyo, Japan
Stress Care Yoshimura Clinic
🇯🇵Fukuoka, Japan
Sugahara Tenjin Clinic
🇯🇵Fukuoka, Japan
Ange Psychiatric Clinic
🇯🇵Fukuoka, Japan
JIN clinic
🇯🇵Osaka, Japan
Sagaarashiyama-Tanaka Clinic
🇯🇵Kyoto, Japan
Medical Corporation Toyokokai Tawara Clinic
🇯🇵Kanagawa, Japan
Shibamoto Clinic
🇯🇵Osakasayama-shi, Osaka, Japan
Meguro sta.East Mental Clinic
🇯🇵Shinagawa-ku, Tokyo, Japan
Omotesando Mental Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Nishi-Shinjuku Concieria Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Himeno Tomomi Clinic
🇯🇵Shinagawa-Ku, Tokyo, Japan
Tamaki Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Akasaka Kato Clinic
🇯🇵Fukuoka, Japan
Eto Mental Clinic Meguro
🇯🇵Tokyo, Japan
Kawamura Mental Clinic
🇯🇵Sapporo, Hokkaido, Japan
Maruyamapark Mentalclinic
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Kanazawa Medical Center
🇯🇵Kanazawa, Ishikawa, Japan