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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441440
• Other study ID #: B2411263
• Status: Completed
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Japan	Suzuki Hospital	Adachi-ku	Tokyo
Japan	Arai Clinic	Amagasaki	Hyogo
Japan	Takahashi Psychiatric Clinic	Ashiya	Hyogo
Japan	Iidabashi Mental Clinic	Chiyoda-ku	Tokyo
Japan	Tutujigaoka Mental Clinic	Chofu	Tokyo
Japan	Akasaka Kato Clinic	Fukuoka
Japan	Ange Psychiatric Clinic	Fukuoka
Japan	Hiro Mental Clinic Tenjinminami	Fukuoka
Japan	Imato Clinic	Fukuoka
Japan	Kuranari Psychiatry Clinic	Fukuoka
Japan	Medical Corporation Shinseikai Kaku Mental Clinic	Fukuoka
Japan	Stress Care Yoshimura Clinic	Fukuoka
Japan	Sugahara Tenjin Clinic	Fukuoka
Japan	Tenjin Mental Clinic	Fukuoka
Japan	Hatsuki Shinryo Clinic	Fukuoka-city	Fukuoka
Japan	Fujikawa Clinic	Hatsukaichi	Hiroshima
Japan	Kuginuki Clinic	Hirakata	Osaka
Japan	Tsuji Mental Clinic	Hiroshima
Japan	Nippon Medical School Chiba Hokusoh Hospital	Inzai	Chiba
Japan	Medical Corporation Toyokokai Tawara Clinic	Kanagawa
Japan	National Hospital Organization Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	Fuku Clinic	Katsushika-ku	Tokyo
Japan	Medical Corporation Seishinkai Kishiro Mental Clinic	Kawasaki	Kanagawa
Japan	Hatakeyama Clinic	Kitakyushu-shi	Fukuoka
Japan	Ikeuchi Psycho Induced Internal Med.Clinic	Kobe	Hyogo
Japan	Tatsuta Clinic	Kobe	Hyogo
Japan	Yuge Hospital	Kumamoto-shi	Kumamoto
Japan	Hayakawa Clinic	Kure	Hiroshima
Japan	Sagaarashiyama-Tanaka Clinic	Kyoto
Japan	Akasaka Clinic	Minato-ku	Tokyo
Japan	SAKURAZAKA CLINIC SophyAnce	Minato-ku	Tokyo
Japan	Hida Clinic	Nagareyama	Chiba
Japan	Mizuho Clinic	Nagoya	Aichi
Japan	Narumi Himawari Clinic	Nagoya	Aichi
Japan	Harikae mental clinic	Nakano-Ku	Tokyo
Japan	Heartcare Ginga Clinic	Nakano-ku	Tokyo
Japan	Kyo Mental Clinic	Nara
Japan	Nakamoto Clinic	Noda City	Chiba
Japan	Shiranui Hospital	Omuta	Fukuoka
Japan	Oka Clinic	Omuta-city	Fukuoka
Japan	JIN clinic	Osaka
Japan	Shibamoto Clinic	Osakasayama-shi	Osaka
Japan	Yutaka Clinic	Sagamihara	Kanagawa
Japan	Misato Ekimae Clinic	Saitama
Japan	Sakai Mental Clinic	Saitama-city	Saitama
Japan	Kawamura Mental Clinic	Sapporo	Hokkaido
Japan	Maruyamapark Mentalclinic	Sapporo	Hokkaido
Japan	Komazawa Mental Clinic	Setagaya-ku	Tokyo
Japan	Sangenjaya Nakamura Mental Clinic	Setagaya-ku	Tokyo
Japan	Maynds Tower Mental Clinic	Shibuya-ku	Tokyo
Japan	Omotesando Mental Clinic	Shibuya-ku	Tokyo
Japan	Yoyoginomori Mental Clinic	Shibuyaku	Tokyo
Japan	Himeno Tomomi Clinic	Shinagawa-Ku	Tokyo
Japan	Meguro sta.East Mental Clinic	Shinagawa-ku	Tokyo
Japan	Kagurazaka Stress Clinic	Shinjuku-ku	Tokyo
Japan	Nishi-Shinjuku Concieria Clinic	Shinjuku-ku	Tokyo
Japan	Tamaki Clinic	Shinjuku-ku	Tokyo
Japan	Tokyo Kosei Nenkin Hospital	Shinjuku-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Eto Mental Clinic Meguro	Tokyo
Japan	Himorogi Psychiatric Institute	Toshima-ku	Tokyo
Japan	Azamino Mental Clinic	Yokohama-Shi	Kanagawa
Japan	Shioiri Mental Clinic	Yokosuka city	Kanagawa

Sponsors (1)

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

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at 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.	Baseline, Week 8 or Early termination
Secondary	Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 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.	Baseline, Week 8 or Early termination
Secondary	Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at 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.	Baseline, Week 8 or Early termination
Secondary	Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at 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.	Baseline, Week 8 or Early termination
Secondary	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	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.	Baseline, Week 8 or Early termination
Secondary	Mean Clinical Global Impression - Improvement (CGI-I) Score at 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.	Baseline, Week 8 or Early termination

External Links

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