Clinical trial NCT01441440: Venlafaxine ER Phase 3 Study for Major Depressive Disorder (MDD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: venlafaxine ER
Major depressive disorder
Japan
placebo-controlled
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-27
Enrollment: 538
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination
timeFrame: Baseline, Week 8 or Early termination
Secondary outcomes:
measure: Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination
timeFrame: Baseline, Week 8 or Early termination
measure: Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination
timeFrame: Baseline, Week 8 or Early termination
measure: Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination
timeFrame: Baseline, Week 8 or Early termination
measure: 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
timeFrame: Baseline, Week 8 or Early termination
measure: Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination
timeFrame: Baseline, Week 8 or Early termination
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Narumi Himawari Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Mizuho Clinic
state: Aichi
city: Inzai
country: Japan
facility: Nippon Medical School Chiba Hokusoh Hospital
state: Chiba
city: Nagareyama
country: Japan
facility: Hida Clinic
state: Chiba
city: Noda City
country: Japan
facility: Nakamoto Clinic
state: Chiba
city: Fukuoka-city
country: Japan
facility: Hatsuki Shinryo Clinic
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hatakeyama Clinic
state: Fukuoka
city: Omuta-city
country: Japan
facility: Oka Clinic
state: Fukuoka
city: Omuta
country: Japan
facility: Shiranui Hospital
state: Fukuoka
city: Hatsukaichi
country: Japan
facility: Fujikawa Clinic
state: Hiroshima
city: Kure
country: Japan
facility: Hayakawa Clinic
state: Hiroshima
city: Sapporo
country: Japan
facility: Kawamura Mental Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Maruyamapark Mentalclinic
state: Hokkaido
city: Amagasaki
country: Japan
facility: Arai Clinic
state: Hyogo
city: Ashiya
country: Japan
facility: Takahashi Psychiatric Clinic
state: Hyogo
city: Kobe
country: Japan
facility: Tatsuta Clinic
state: Hyogo
city: Kobe
country: Japan
facility: Ikeuchi Psycho Induced Internal Med.Clinic
state: Hyogo
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
state: Ishikawa
city: Kawasaki
country: Japan
facility: Medical Corporation Seishinkai Kishiro Mental Clinic
state: Kanagawa
city: Sagamihara
country: Japan
facility: Yutaka Clinic
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Azamino Mental Clinic
state: Kanagawa
city: Yokosuka city
country: Japan
facility: Shioiri Mental Clinic
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Yuge Hospital
state: Kumamoto
city: Hirakata
country: Japan
facility: Kuginuki Clinic
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Shibamoto Clinic
state: Osaka
city: Saitama-city
country: Japan
facility: Sakai Mental Clinic
state: Saitama
city: Adachi-ku
country: Japan
facility: Suzuki Hospital
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Iidabashi Mental Clinic
state: Tokyo
city: Chofu
country: Japan
facility: Tutujigaoka Mental Clinic
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Fuku Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: SAKURAZAKA CLINIC SophyAnce
state: Tokyo
city: Minato-ku
country: Japan
facility: Akasaka Clinic
state: Tokyo
city: Nakano-Ku
country: Japan
facility: Harikae mental clinic
state: Tokyo
city: Nakano-ku
country: Japan
facility: Heartcare Ginga Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Sangenjaya Nakamura Mental Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Komazawa Mental Clinic
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Omotesando Mental Clinic
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Maynds Tower Mental Clinic
state: Tokyo
city: Shibuyaku
country: Japan
facility: Yoyoginomori Mental Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Meguro sta.East Mental Clinic
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: Himeno Tomomi Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Nishi-Shinjuku Concieria Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tamaki Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Kagurazaka Stress Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Kosei Nenkin Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Toshima-ku
country: Japan
facility: Himorogi Psychiatric Institute
state: Tokyo
city: Fukuoka
country: Japan
facility: Sugahara Tenjin Clinic
city: Fukuoka
country: Japan
facility: Hiro Mental Clinic Tenjinminami
city: Fukuoka
country: Japan
facility: Tenjin Mental Clinic
city: Fukuoka
country: Japan
facility: Medical Corporation Shinseikai Kaku Mental Clinic
city: Fukuoka
country: Japan
facility: Ange Psychiatric Clinic
city: Fukuoka
country: Japan
facility: Stress Care Yoshimura Clinic
city: Fukuoka
country: Japan
facility: Kuranari Psychiatry Clinic
city: Fukuoka
country: Japan
facility: Akasaka Kato Clinic
city: Fukuoka
country: Japan
facility: Imato Clinic
city: Hiroshima
country: Japan
facility: Tsuji Mental Clinic
city: Kanagawa
country: Japan
facility: Medical Corporation Toyokokai Tawara Clinic
city: Kyoto
country: Japan
facility: Sagaarashiyama-Tanaka Clinic
city: Nara
country: Japan
facility: Kyo Mental Clinic
city: Osaka
country: Japan
facility: JIN clinic
city: Saitama
country: Japan
facility: Misato Ekimae Clinic
city: Tokyo
country: Japan
facility: Eto Mental Clinic Meguro
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.