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Major Depressive DisorderPhase 3NCT01485887

Venlafaxine ER Long-Term Extension Study for Major Depressive Disorder (MDD)

A Phase 3 study testing Venlafaxine ER in people with Major Depressive Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 25 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, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
25 sitesJapan
Study dates
Jan 2012to Jan 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

  • Outpatients who have completed 8 weeks double-blind study (B2411263), without major protocol violations or tolerability concerns in the opinion of the investigator.

Who cannot join

  • Clinically important abnormalities on baseline (Week 8 of the double-blind study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before Week 8 in the previous double-blind study.
  • Significant risk of suicide based on clinical judgment.
  • Use of prohibited treatments

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Japan25 sites

  • Suzuki Hospital

    Adachi-ku, Tokyo, 120-0033

  • Takahashi Psychiatric Clinic

    Ashiya, Hyōgo, 659-0093

  • Stress Care Yoshimura Clinic

    Fukuoka, Fukuoka, 810-0041

  • Tenjin Mental Clinic

    Fukuoka, 810-0004

  • Stress Care Yoshimura Clinic

    Fukuoka, 810-0041

  • Kuranari Psychiatry Clinic

    Fukuoka, 810-0801

  • Fujikawa Clinic

    Hatsukaichi, Hiroshima, 738-0023

  • 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

  • Medical Corporation Seishinkai Kishiro Mental Clinic

    Kawasaki, Kanagawa, 214-0014

  • Hatakeyama Clinic

    Kitakyushu, Fukuoka, 802-0064

  • Ikeuchi Psycho Induced Internal Med.Clinic

    Kobe, Hyōgo, 655-0037

  • Sagaarashiyama-Tanaka Clinic

    Kyoto, 616-8421

  • Nakamoto Clinic

    Noda, Chiba, 278-0033

  • Shiranui Hospital

    Omuta, Fukuoka, 836-0004

  • Shibamoto Clinic

    Osakasayama-shi, Osaka, 589-0011

  • Yutaka Clinic

    Sagamihara-shi, Kanagawa, 252-0303

  • Sangenjaya Nakamura Mental Clinic

    Setagaya-ku, Tokyo, 154-0004

  • Omotesando Mental Clinic

    Shibuya-ku, Tokyo, 150-0001

  • Maynds Tower Mental Clinic

    Shibuya-ku, Tokyo, 151-0053

  • Tokyo Kosei Nenkin Hospital

    Shinjuku-ku, Tokyo, 162-8543

  • Himorogi Psychiatric Institute

    Toshima-ku, Tokyo, 170-0002

  • Tawara Clinic

    Yokohama, Kanagawa, 221-0835

  • Shioiri Mental Clinic

    Yokosuka, Kanagawa, 238-0042

Other trials in Japan

About this study

Official title: A Open-label Long-term Extension Study To Evaluate The Safety And Efficacy Of Venlafaxine Er In Adult Outpatients With Major Depressive Disorder

This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.

Being tested
Venlafaxine ER
Keywords
Venlafaxine ER, long-term extension, Japan
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 ERDrug

    Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration

Study groups in NCT01485887
Study groupRoleWhat they receive
Venlafaxine ERExperimentalNot described
Receives: Drug: Venlafaxine ER

What is being measured

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

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.

    Measured: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

  2. Number of Participants With Clinical Significant Vital Changes

    Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP >= 90 mmHg with change from the baseline >= 10 mmHg; SBP >= 140 mmHg with change from the baseline >= 20 mmHg; PR >= 100 bpm with change from the baseline >= 15 bpm.

    Measured: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

  3. Number of Participants With Clinical Significant Laboratory Tests Changes

    Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count <0.8 x lower limit normal (LLN); Lymphocytes (%) <0.8 x LLN; Eosinophils (%) >1.2 x upper limit normal (ULN); Total Bilirubin >1.5 x ULN; Alanine Aminotransferase (ALT) >3.0 x ULN; Gamma glutamyl transferase (GGT) >3.0 x ULN; Uric Acid >1.2 x ULN; Cholesterol >1.3 x ULN; Low density lipoprotein (LDL) cholesterol >1.2 x ULN; Triglycerides >1.3 x ULN; Glucose >1.5 x ULN; Urine Glucose [qualitative (Qual)] >=1; Urine Protein (Qual) >=1; Urine Blood/Hemoglobin (Hgb) (Qual) >=1.

    Measured: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

  4. Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes

    Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)> 450 millisecond (ms), >480 ms, and >500 ms respsctively, change from baseline in QTc, QTcB, and QTcF >= 30 ms, and >= 60 ms, respectively.

    Measured: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

  5. Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories

    C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.

    Measured: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months

Secondary outcomes (4)

  1. Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point

    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 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.

    Measured: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44

  2. Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point

    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 observation minus mean score at baseline.

    Measured: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44

  3. Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point

    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: Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44

  4. Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point

    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, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.

    Measured: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44

Timeline

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

  1. First posted6 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2014
  4. Study completionJan 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01485887
Sponsor's protocol ID
B2411264
Status last verified
Jan 2021
First submitted
29 Nov 2011
Last updated
28 Jan 2021
Data monitoring committee
No

Publications

  • 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 in people with Major Depressive Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 25 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 1 inclusion and 3 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 25 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. 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 15 May 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?

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months). The study lists 5 primary outcomes in all. 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 NCT01485887, which also lists 1 linked publication.

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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