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

NCT01441440 | Completed Phase 3 Results

• 1 other identifier: B2411263
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 63

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.

Conditions

Major Depressive Disorder

Keywords

venlafaxine ER; Major depressive disorder; Japan; placebo-controlled

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Baseline, Week 8 or Early termination

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

  Baseline, 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

  Baseline, 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

  Baseline, Week 8 or Early termination

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

  Baseline, Week 8 or Early termination

Study Arms (3)

venlafaxine ER 75 mg/day (fixed dose)

EXPERIMENTAL

Drug: venlafaxine ER 75 mg/day (fixed dose)

venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)

EXPERIMENTAL

Drug: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

venlafaxine ER 75 mg/day (fixed dose) DRUG

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 (fixed dose)

venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) DRUG

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

venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (63)

Narumi Himawari Clinic

Nagoya, Aichi-ken, 458-0801, Japan

Location

Mizuho Clinic

Nagoya, Aichi-ken, 467-0806, Japan

Location

Nippon Medical School Chiba Hokusoh Hospital

Inzai, Chiba, 270-1694, Japan

Location

Hida Clinic

Nagareyama, Chiba, 270-0163, Japan

Location

Nakamoto Clinic

Noda, Chiba, 278-0033, Japan

Location

Hatsuki Shinryo Clinic

Fukuoka, Fukuoka, 814-0104, Japan

Location

Hatakeyama Clinic

Kitakyushu-shi, Fukuoka, 802-0064, Japan

Location

Shiranui Hospital

Omuta, Fukuoka, 836-0004, Japan

Location

Oka Clinic

Omuta, Fukuoka, 836-0044, Japan

Location

Fujikawa Clinic

Hatsukaichi, Hiroshima, 738-0023, Japan

Location

Hayakawa Clinic

Kure, Hiroshima, 737-0111, Japan

Location

Kawamura Mental Clinic

Sapporo, Hokkaido, 001-0023, Japan

Location

Maruyamapark Mentalclinic

Sapporo, Hokkaido, 064-0820, Japan

Location

Arai Clinic

Amagasaki, Hyōgo, 660-0882, Japan

Location

Takahashi Psychiatric Clinic

Ashiya, Hyōgo, 659-0093, Japan

Location

Tatsuta Clinic

Kobe, Hyōgo, 651-0097, Japan

Location

Ikeuchi Psycho Induced Internal Med.Clinic

Kobe, Hyōgo, 655-0037, Japan

Location

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, 920-8650, Japan

Location

Medical Corporation Seishinkai Kishiro Mental Clinic

Kawasaki, Kanagawa, 214-0014, Japan

Location

Yutaka Clinic

Sagamihara, Kanagawa, 252-0303, Japan

Location

Azamino Mental Clinic

Yokohama, Kanagawa, 225-0011, Japan

Location

Shioiri Mental Clinic

Yokosuka, Kanagawa, 238-0042, Japan

Location

Yuge Hospital

Kumamoto, Kumamoto, 861-8002, Japan

Location

Kuginuki Clinic

Hirakata, Osaka, 573-0032, Japan

Location

Shibamoto Clinic

Osakasayama-shi, Osaka, 589-0011, Japan

Location

Sakai Mental Clinic

Saitama, Saitama, 330-0062, Japan

Location

Suzuki Hospital

Adachi-ku, Tokyo, 120-0033, Japan

Location

Iidabashi Mental Clinic

Chiyoda-ku, Tokyo, 102-0071, Japan

Location

Tutujigaoka Mental Clinic

Chōfu, Tokyo, 182-0006, Japan

Location

Fuku Clinic

Katsushika-ku, Tokyo, 125-0041, Japan

Location

SAKURAZAKA CLINIC SophyAnce

Minato-ku, Tokyo, 106-0032, Japan

Location

Akasaka Clinic

Minato-ku, Tokyo, 107-0052, Japan

Location

Harikae mental clinic

Nakano-Ku, Tokyo, 164-0001, Japan

Location

Heartcare Ginga Clinic

Nakano-ku, Tokyo, 164-0012, Japan

Location

Sangenjaya Nakamura Mental Clinic

Setagaya-ku, Tokyo, 154-0004, Japan

Location

Komazawa Mental Clinic

Setagaya-ku, Tokyo, 154-0012, Japan

Location

Omotesando Mental Clinic

Shibuya-ku, Tokyo, 150-0001, Japan

Location

Maynds Tower Mental Clinic

Shibuya-ku, Tokyo, 151-0053, Japan

Location

Yoyoginomori Mental Clinic

Shibuyaku, Tokyo, 151-0053, Japan

Location

Meguro sta.East Mental Clinic

Shinagawa-ku, Tokyo, 141-0021, Japan

Location

Himeno Tomomi Clinic

Shinagawa-Ku, Tokyo, 141-0032, Japan

Location

Nishi-Shinjuku Concieria Clinic

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Tamaki Clinic

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Kagurazaka Stress Clinic

Shinjuku-ku, Tokyo, 162-0825, Japan

Location

Tokyo Kosei Nenkin Hospital

Shinjuku-ku, Tokyo, 162-8543, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Himorogi Psychiatric Institute

Toshima-ku, Tokyo, 170-0002, Japan

Location

Sugahara Tenjin Clinic

Fukuoka, 810-0001, Japan

Location

Hiro Mental Clinic Tenjinminami

Fukuoka, 810-0004, Japan

Location

Tenjin Mental Clinic

Fukuoka, 810-0004, Japan

Location

Medical Corporation Shinseikai Kaku Mental Clinic

Fukuoka, 810-0022, Japan

Location

Ange Psychiatric Clinic

Fukuoka, 810-0035, Japan

Location

Stress Care Yoshimura Clinic

Fukuoka, 810-0041, Japan

Location

Kuranari Psychiatry Clinic

Fukuoka, 810-0801, Japan

Location

Akasaka Kato Clinic

Fukuoka, 8100041, Japan

Location

Imato Clinic

Fukuoka, 815-0041, Japan

Location

Tsuji Mental Clinic

Hiroshima, 731-0112, Japan

Location

Medical Corporation Toyokokai Tawara Clinic

Kanagawa, 221-0835, Japan

Location

Sagaarashiyama-Tanaka Clinic

Kyoto, 616-8421, Japan

Location

Kyo Mental Clinic

Nara, 631-0036, Japan

Location

JIN clinic

Osaka, 530-0041, Japan

Location

Misato Ekimae Clinic

Saitama, 341-0018, Japan

Location

Eto Mental Clinic Meguro

Tokyo, 142-0021, Japan

Location

Related Publications (2)

• 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.

  PMID: 32912597 DERIVED

• 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.

  PMID: 26513202 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inuiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 27, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 28, 2021
• Results First Posted: March 13, 2015

Record last verified: 2015-03

Locations

JP (63)