A Phase 3 interventional study of Venlafaxine ER in Major Depressive Disorder, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 25 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Time frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
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.
Time frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
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.
Time frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
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.
Time frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
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.
Time frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months
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.
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
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.
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
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.
Time frame: Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44
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.
Time frame: Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44
| Milestone | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Started | 50 |
| Completed | 38 |
| Not completed | 12 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Adverse event | 8 |
| Withdrew: Deterioration of primary disease | 1 |
| Withdrew: Primary disease markedly improved | 1 |
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.
| Participants | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Adverse events (AEs) | 49 |
| Serious adverse events (SAEs) | 2 |
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.
| Participants | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Systoloc blood pressure (SBP) | 3 |
| Diastolic bloodpressure (DBP) | 4 |
| Pulse rate | 1 |
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.
| Participants | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Red Blood Cell Count < 0.8xLLN | 1 |
| Lymphocytes (%) < 0.8xLLN | 2 |
| Eosinophils (%) > 1.2xULN | 3 |
| Total Bilirubin > 1.5xULN | 1 |
| ALT > 3.0xULN | 1 |
| GGT > 3.0xULN | 4 |
| Uric Acid > 1.2xULN | 1 |
| Cholesterol > 1.3xULN | 4 |
| LDL Cholestero l> 1.2xULN | 12 |
| Triglycerides > 1.3xULN | 8 |
| Glucose > 1.5xULN | 3 |
| Urine Glucose (Qual) >= 1 | 3 |
| Urine Protein (Qual) >= 1 | 3 |
| Urine Blood/Hgb(Qual) >= 1 | 10 |
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.
| Participants | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| QT Interval > 450 ms | 5 |
| QT Interval > 480 ms | 0 |
| QT Interval > 500 ms | 0 |
| QTcB Interval > 450 ms | 17 |
| QTcB Interval > 480 ms | 4 |
| QTcB Interval > 500 ms | 1 |
| QTcF Interval > 450 ms | 8 |
| QTcF Interval > 480 ms | 1 |
| QTcF Interval > 500 ms | 0 |
| QT Interval increase from baseline >= 30 ms | 7 |
| QT Interval increase from baseline >= 60 ms | 0 |
| QTcB Interval increase from baseline >= 30 ms | 8 |
| QTcB Interval increase from baseline >= 60 ms | 0 |
| QTcF Interval increase from baseline >= 30 ms | 4 |
| QTcF Interval increase from baseline >= 60 ms | 0 |
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.
| Participants | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Completed suicide | 0 |
| Suicide attempt | 0 |
| Preparatory acts toward imminent suicidal behavior | 0 |
| Suicide ideation | 0 |
| Self-injurious behavior, no suicidal intent | 0 |
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.
| Units on a scale | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Week 1 (n=50) | -1.0 ± 2.00 |
| Week 2 (n=50) | -1.5 ± 3.47 |
| Week 3 (n=50) | -2.2 ± 4.76 |
| Week 4 (n=50) | -2.9 ± 4.55 |
| Week 6 (n=47) | -3.4 ± 4.39 |
| Week 8 (n=48) | -3.9 ± 4.61 |
| Week 12 (n=47) | -4.1 ± 5.41 |
| Week 16 (n=46) | -4.4 ± 7.06 |
| Week 20 (n=45) | -6.2 ± 4.93 |
| Week 24 (n=44) | -5.7 ± 5.08 |
| Week 28 (n=42) | -6.1 ± 5.67 |
| Week 32 (n=41) | -6.4 ± 5.81 |
| Week 36 (n=41) | -6.5 ± 5.85 |
| Week 40 (n=40) | -6.4 ± 6.55 |
| Week 44 (n=40) | -7.1 ± 5.98 |
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.
| Units on a scale | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Week 1 (n=50) | -0.1 ± 0.46 |
| Week 2 (n=50) | -0.3 ± 0.63 |
| Week 3 (n=50) | -0.3 ± 0.87 |
| Week 4 (n=50) | -0.4 ± 0.81 |
| Week 6 (n=47) | -0.6 ± 0.77 |
| Week 8 (n=48) | -0.6 ± 0.91 |
| Week 12 (n=47) | -0.8 ± 1.20 |
| Week 16 (n=46) | -0.9 ± 1.34 |
| Week 20 (n=45) | -1.2 ± 0.98 |
| Week 24 (n=44) | -1.1 ± 1.01 |
| Week 28 (n=42) | -1.2 ± 1.07 |
| Week 32 (n=41) | -1.2 ± 1.11 |
| Week 36 (n=41) | -1.2 ± 1.19 |
| Week 40 (n=40) | -1.2 ± 1.23 |
| Week 44 (n=40) | -1.3 ± 1.12 |
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.
| Units on a scale | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Week 1 (n=50) | 3.8 ± 0.62 |
| Week 2 (n=50) | 3.5 ± 0.81 |
| Week 3 (n=50) | 3.3 ± 1.05 |
| Week 4 (n=50) | 3.1 ± 1.05 |
| Week 6 (n=47) | 2.9 ± 0.91 |
| Week 8 (n=48) | 2.9 ± 0.96 |
| Week 12 (n=47) | 2.6 ± 1.06 |
| Week 16 (n=46) | 2.4 ± 1.20 |
| Week 20 (n=45) | 2.1 ± 0.97 |
| Week 24 (n=44) | 2.2 ± 1.05 |
| Week 28 (n=42) | 2.2 ± 1.09 |
| Week 32 (n=41) | 2.1 ± 1.14 |
| Week 36 (n=41) | 2.2 ± 1.18 |
| Week 40 (n=40) | 2.1 ± 1.25 |
| Week 44 (n=40) | 2.0 ± 1.15 |
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.
| Units on a scale | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Week 12 (n=47) | -2.7 ± 4.97 |
| Week 24 (n=44) | -3.8 ± 4.45 |
| Week 44 (n=40) | -4.7 ± 4.73 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Venlafaxine ER 75-225 mg/Day Flexible | — | 2/50 (4%) | 49/50 (98%) |
| Event | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| PyrexiaGeneral disorders | 1/50 |
| CrimeSocial circumstances | 1/50 |
| Event | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| NasopharyngitisInfections and infestations | 20/50 |
| HeadacheNervous system disorders | 13/50 |
| DizzinessNervous system disorders | 11/50 |
| SomnolenceNervous system disorders | 9/50 |
| ConstipationGastrointestinal disorders | 7/50 |
| NauseaGastrointestinal disorders | 7/50 |
| Blood pressure increasedInvestigations | 7/50 |
| Feeling abnormalGeneral disorders | 6/50 |
| InsomniaPsychiatric disorders | 6/50 |
| HypertensionVascular disorders | 6/50 |
| Age, Continuous(years) | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| Mean | 43.7 ± 13.6 |
| Sex: Female, Male(Participants) | Venlafaxine ER 75-225 mg/Day Flexible |
|---|---|
| FEMALE | 26 |
| MALE | 24 |
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.