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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485887
• Other study ID #: B2411264
• Status: Completed
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Japan	Suzuki Hospital	Adachi-ku	Tokyo
Japan	Takahashi Psychiatric Clinic	Ashiya	Hyogo
Japan	Kuranari Psychiatry Clinic	Fukuoka
Japan	Stress Care Yoshimura Clinic	Fukuoka
Japan	Tenjin Mental Clinic	Fukuoka
Japan	Stress Care Yoshimura Clinic	Fukuoka-shi	Fukuoka
Japan	Fujikawa Clinic	Hatsukaichi	Hiroshima
Japan	Nippon Medical School Chiba Hokusoh Hospital	Inzai	Chiba
Japan	Medical Corporation Toyokokai Tawara Clinic	Kanagawa
Japan	National Hospital Organization Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	Medical Corporation Seishinkai Kishiro Mental Clinic	Kawasaki	Kanagawa
Japan	Hatakeyama Clinic	Kitakyushu	Fukuoka
Japan	Ikeuchi Psycho Induced Internal Med.Clinic	Kobe	Hyogo
Japan	Sagaarashiyama-Tanaka Clinic	Kyoto
Japan	Nakamoto Clinic	Noda City	Chiba
Japan	Shiranui Hospital	Omuta	Fukuoka
Japan	Shibamoto Clinic	Osakasayama-shi	Osaka
Japan	Yutaka Clinic	Sagamihara-shi	Kanagawa
Japan	Sangenjaya Nakamura Mental Clinic	Setagaya-ku	Tokyo
Japan	Maynds Tower Mental Clinic	Shibuya-ku	Tokyo
Japan	Omotesando Mental Clinic	Shibuya-ku	Tokyo
Japan	Tokyo Kosei Nenkin Hospital	Shinjuku-ku	Tokyo
Japan	Himorogi Psychiatric Institute	Toshima-ku	Tokyo
Japan	Tawara Clinic	Yokohama	Kanagawa
Japan	Shioiri Mental Clinic	Yokosuka city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
Primary	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.	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
Primary	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.	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
Primary	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.	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
Primary	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.	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
Secondary	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.	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
Secondary	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.	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
Secondary	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.	Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44
Secondary	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.	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44

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