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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01485887
First received: November 29, 2011
Last updated: September 30, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder
Drug: Venlafaxine ER
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Clinical Significant Vital Changes [ Time Frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Clinical Significant Laboratory Tests Changes [ Time Frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes [ Time Frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months ] [ Designated as safety issue: Yes ]
    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.

  • 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 [ Time Frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point [ Time Frame: Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point [ Time Frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44 ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: January 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venlafaxine ER Drug: Venlafaxine ER
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

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485887

Locations
Japan
Nippon Medical School Chiba Hokusoh Hospital
Inzai, Chiba, Japan, 270-1694
Nakamoto Clinic
Noda City, Chiba, Japan, 278-0033
Stress Care Yoshimura Clinic
Fukuoka-shi, Fukuoka, Japan, 810-0041
Hatakeyama Clinic
Kitakyushu, Fukuoka, Japan, 802-0064
Shiranui Hospital
Omuta, Fukuoka, Japan, 836-0004
Fujikawa Clinic
Hatsukaichi, Hiroshima, Japan, 738-0023
Takahashi Psychiatric Clinic
Ashiya, Hyogo, Japan, 659-0093
Ikeuchi Psycho Induced Internal Med.Clinic
Kobe, Hyogo, Japan, 655-0037
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa, Japan, 920-8650
Medical Corporation Seishinkai Kishiro Mental Clinic
Kawasaki, Kanagawa, Japan, 214-0014
Yutaka Clinic
Sagamihara-shi, Kanagawa, Japan, 252-0303
Tawara Clinic
Yokohama, Kanagawa, Japan, 221-0835
Shioiri Mental Clinic
Yokosuka city, Kanagawa, Japan, 238-0042
Shibamoto Clinic
Osakasayama-shi, Osaka, Japan, 589-0011
Suzuki Hospital
Adachi-ku, Tokyo, Japan, 120-0033
Sangenjaya Nakamura Mental Clinic
Setagaya-ku, Tokyo, Japan, 154-0004
Omotesando Mental Clinic
Shibuya-ku, Tokyo, Japan, 150-0001
Maynds Tower Mental Clinic
Shibuya-ku, Tokyo, Japan, 151-0053
Tokyo Kosei Nenkin Hospital
Shinjuku-ku, Tokyo, Japan, 162-8543
Himorogi Psychiatric Institute
Toshima-ku, Tokyo, Japan, 170-0002
Tenjin Mental Clinic
Fukuoka, Japan, 810-0004
Stress Care Yoshimura Clinic
Fukuoka, Japan, 810-0041
Kuranari Psychiatry Clinic
Fukuoka, Japan, 810-0801
Medical Corporation Toyokokai Tawara Clinic
Kanagawa, Japan, 221-0835
Sagaarashiyama-Tanaka Clinic
Kyoto, Japan, 616-8421
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01485887     History of Changes
Other Study ID Numbers: B2411264 
Study First Received: November 29, 2011
Results First Received: January 9, 2015
Last Updated: September 30, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Venlafaxine ER
long-term extension
Japan

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on December 02, 2016