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Major Depressive DisorderPhase 3NCT01441440

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

A Phase 3 study testing venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) in people with Major Depressive Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 63 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
538 participants
Where
63 sitesJapan
Study dates
Nov 2011to Mar 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

Japan63 sites

  • Suzuki Hospital

    Adachi-ku, Tokyo, 120-0033

  • Arai Clinic

    Amagasaki, Hyōgo, 660-0882

  • Takahashi Psychiatric Clinic

    Ashiya, Hyōgo, 659-0093

  • Iidabashi Mental Clinic

    Chiyoda-ku, Tokyo, 102-0071

  • Tutujigaoka Mental Clinic

    Chōfu, Tokyo, 182-0006

  • Hatsuki Shinryo Clinic

    Fukuoka, Fukuoka, 814-0104

  • Sugahara Tenjin Clinic

    Fukuoka, 810-0001

  • Hiro Mental Clinic Tenjinminami

    Fukuoka, 810-0004

  • Tenjin Mental Clinic

    Fukuoka, 810-0004

  • Medical Corporation Shinseikai Kaku Mental Clinic

    Fukuoka, 810-0022

  • Ange Psychiatric Clinic

    Fukuoka, 810-0035

  • Stress Care Yoshimura Clinic

    Fukuoka, 810-0041

  • Kuranari Psychiatry Clinic

    Fukuoka, 810-0801

  • Akasaka Kato Clinic

    Fukuoka, 8100041

  • Imato Clinic

    Fukuoka, 815-0041

  • Fujikawa Clinic

    Hatsukaichi, Hiroshima, 738-0023

  • Kuginuki Clinic

    Hirakata, Osaka, 573-0032

  • Tsuji Mental Clinic

    Hiroshima, 731-0112

  • Nippon Medical School Chiba Hokusoh Hospital

    Inzai, Chiba, 270-1694

  • Medical Corporation Toyokokai Tawara Clinic

    Kanagawa, 221-0835

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

  • Fuku Clinic

    Katsushika-ku, Tokyo, 125-0041

  • Medical Corporation Seishinkai Kishiro Mental Clinic

    Kawasaki, Kanagawa, 214-0014

  • Hatakeyama Clinic

    Kitakyushu-shi, Fukuoka, 802-0064

  • Tatsuta Clinic

    Kobe, Hyōgo, 651-0097

  • Ikeuchi Psycho Induced Internal Med.Clinic

    Kobe, Hyōgo, 655-0037

  • Yuge Hospital

    Kumamoto, Kumamoto, 861-8002

  • Hayakawa Clinic

    Kure, Hiroshima, 737-0111

  • Sagaarashiyama-Tanaka Clinic

    Kyoto, 616-8421

  • SAKURAZAKA CLINIC SophyAnce

    Minato-ku, Tokyo, 106-0032

  • Akasaka Clinic

    Minato-ku, Tokyo, 107-0052

  • Hida Clinic

    Nagareyama, Chiba, 270-0163

  • Narumi Himawari Clinic

    Nagoya, Aichi-ken, 458-0801

  • Mizuho Clinic

    Nagoya, Aichi-ken, 467-0806

  • Heartcare Ginga Clinic

    Nakano-ku, Tokyo, 164-0012

  • Harikae mental clinic

    Nakano-Ku, Tokyo, 164-0001

  • Kyo Mental Clinic

    Nara, 631-0036

  • Nakamoto Clinic

    Noda, Chiba, 278-0033

  • Shiranui Hospital

    Omuta, Fukuoka, 836-0004

  • Oka Clinic

    Omuta, Fukuoka, 836-0044

  • JIN clinic

    Osaka, 530-0041

  • Shibamoto Clinic

    Osakasayama-shi, Osaka, 589-0011

  • Yutaka Clinic

    Sagamihara, Kanagawa, 252-0303

  • Sakai Mental Clinic

    Saitama, Saitama, 330-0062

  • Misato Ekimae Clinic

    Saitama, 341-0018

  • Kawamura Mental Clinic

    Sapporo, Hokkaido, 001-0023

  • Maruyamapark Mentalclinic

    Sapporo, Hokkaido, 064-0820

  • Sangenjaya Nakamura Mental Clinic

    Setagaya-ku, Tokyo, 154-0004

  • Komazawa Mental Clinic

    Setagaya-ku, Tokyo, 154-0012

  • Omotesando Mental Clinic

    Shibuya-ku, Tokyo, 150-0001

  • Maynds Tower Mental Clinic

    Shibuya-ku, Tokyo, 151-0053

  • Yoyoginomori Mental Clinic

    Shibuyaku, Tokyo, 151-0053

  • Meguro sta.East Mental Clinic

    Shinagawa-ku, Tokyo, 141-0021

  • Himeno Tomomi Clinic

    Shinagawa-Ku, Tokyo, 141-0032

  • Nishi-Shinjuku Concieria Clinic

    Shinjuku-ku, Tokyo, 160-0023

  • Tamaki Clinic

    Shinjuku-ku, Tokyo, 160-0023

  • Kagurazaka Stress Clinic

    Shinjuku-ku, Tokyo, 162-0825

  • Tokyo Kosei Nenkin Hospital

    Shinjuku-ku, Tokyo, 162-8543

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, Tokyo, 162-8666

  • Eto Mental Clinic Meguro

    Tokyo, 142-0021

  • Himorogi Psychiatric Institute

    Toshima-ku, Tokyo, 170-0002

  • Azamino Mental Clinic

    Yokohama, Kanagawa, 225-0011

  • Shioiri Mental Clinic

    Yokosuka, Kanagawa, 238-0042

Other trials in Japan

About this study

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

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.

Being tested
venlafaxine ER 75 mg/day (fixed dose), venlafaxine ER 75 mg/day to 225 mg/day (flexible dose), Placebo
Keywords
venlafaxine ER, Major depressive disorder, Japan, placebo-controlled
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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

  • PlaceboDrug

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

Study groups in NCT01441440
Study groupRoleWhat they receive
venlafaxine ER 75 mg/day (fixed dose)ExperimentalNot described
Receives: Drug: venlafaxine ER 75 mg/day (fixed dose)
venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)ExperimentalNot described
Receives: Drug: venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 8 or Early termination

Secondary outcomes (5)

  1. 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.

    Measured: Baseline, Week 8 or Early termination

  2. 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.

    Measured: Baseline, Week 8 or Early termination

  3. 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.

    Measured: Baseline, Week 8 or Early termination

  4. 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.

    Measured: Baseline, Week 8 or Early termination

  5. 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.

    Measured: Baseline, Week 8 or Early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01441440
Sponsor's protocol ID
B2411263
Status last verified
Mar 2015
First submitted
23 Sep 2011
Last updated
28 Jan 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 32912597

  • 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.

    PubMed 26513202

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing venlafaxine ER 75 mg/day (fixed dose) and venlafaxine ER 75 mg/day to 225 mg/day (flexible dose) in people with Major Depressive Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 63 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination (time frame: Baseline, Week 8 or Early termination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01441440, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.

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