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

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Venlafaxine ER

Registration Number: NCT01485887

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

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venlafaxine ER	Venlafaxine ER	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Significant Laboratory Tests Changes	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months	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 Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months	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 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	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months	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.
Number of Participants With Clinical Significant Vital Changes	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months	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 Electrocardiogram (ECG) Changes	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point	Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44	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.
Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point	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	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	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	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	Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44	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.

Trial Locations

Locations (24): Suzuki Hospital
🇯🇵
Adachi-ku, Tokyo, Japan
Nippon Medical School Chiba Hokusoh Hospital
🇯🇵
Inzai, Chiba, Japan
Shibamoto Clinic
🇯🇵
Osakasayama-shi, Osaka, Japan
Kuranari Psychiatry Clinic
🇯🇵
Fukuoka, Japan
Medical Corporation Toyokokai Tawara Clinic
🇯🇵
Kanagawa, Japan
Nakamoto Clinic
🇯🇵
Noda City, Chiba, Japan
National Hospital Organization Kanazawa Medical Center
🇯🇵
Kanazawa, Ishikawa, Japan
Omotesando Mental Clinic
🇯🇵
Shibuya-ku, Tokyo, Japan
Tokyo Kosei Nenkin Hospital
🇯🇵
Shinjuku-ku, Tokyo, Japan
Takahashi Psychiatric Clinic
🇯🇵
Ashiya, Hyogo, Japan
Shioiri Mental Clinic
🇯🇵
Yokosuka city, Kanagawa, Japan
Maynds Tower Mental Clinic
🇯🇵
Shibuya-ku, Tokyo, Japan
Medical Corporation Seishinkai Kishiro Mental Clinic
🇯🇵
Kawasaki, Kanagawa, Japan
Stress Care Yoshimura Clinic
🇯🇵
Fukuoka, Japan
Shiranui Hospital
🇯🇵
Omuta, Fukuoka, Japan
Hatakeyama Clinic
🇯🇵
Kitakyushu, Fukuoka, Japan
Yutaka Clinic
🇯🇵
Sagamihara-shi, Kanagawa, Japan
Sangenjaya Nakamura Mental Clinic
🇯🇵
Setagaya-ku, Tokyo, Japan
Fujikawa Clinic
🇯🇵
Hatsukaichi, Hiroshima, Japan
Ikeuchi Psycho Induced Internal Med.Clinic
🇯🇵
Kobe, Hyogo, Japan
Tawara Clinic
🇯🇵
Yokohama, Kanagawa, Japan
Himorogi Psychiatric Institute
🇯🇵
Toshima-ku, Tokyo, Japan
Tenjin Mental Clinic
🇯🇵
Fukuoka, Japan
Sagaarashiyama-Tanaka Clinic
🇯🇵
Kyoto, Japan