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| ID | Type | Description | Link |
|---|---|---|---|
| B2061010 |
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Study Comparing Discontinuation Symptoms in subjects with Major Depressive Disorder treated for 24 Weeks with Open-label 50 mg Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desvenlafaxine Succinate Sustained-Release Formulation 50 mg | Active Comparator |
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| Desvenlafaxine Succinate Sustained-Release Formulation 25 mg | Active Comparator |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine Succinate Sustained-Release Formulation 50 mg | Drug | DVS SR 50 mg Reference Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase | Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2). | Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase | Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26137358 | Derived | Ninan PT, Musgnung J, Messig M, Buckley G, Guico-Pabia CJ, Ramey TS. Incidence and Timing of Taper/Posttherapy-Emergent Adverse Events Following Discontinuation of Desvenlafaxine 50 mg/d in Patients With Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 5;17(1):10.4088/PCC.14m01715. doi: 10.4088/PCC.14m01715. eCollection 2015. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Eligible participants entered a 24 Week Open-label treatment phase; participants who completed the Open-label phase were randomized to a 4 Week Double-blind treatment phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | DVS SR 50 mg (Open-label Phase) | Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks. |
| FG001 | DVS SR 50 mg (Double-blind Phase) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Phase |
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| Desvenlafaxine Succinate Sustained-Release Formulation 25 mg | Drug | DVS SR 25 mg Taper Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase. |
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| Placebo | Drug | DVS SR Placebo Abrupt Discontinuation Group/Arm, oral tablet, 2 tablets/day during the first week and 1 tablet/day during weeks 2 through 4 of the double-blind treatment phase. |
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| Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196) |
| Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms | Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms. | Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196) |
DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
| FG002 | DVS SR 25 mg (Double-blind Phase) | DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4. |
| FG003 | Placebo (Double-blind Phase) | Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4. |
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| NOT COMPLETED |
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| Double-blind Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | 24 Week Open-label phase DVS SR 50 mg PO QD followed by 4 Week Double-blind phase: DVS SR 50 mg (reference group), DVS SR 25 mg (taper group), or Placebo (abrupt-discontinuation group). |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Total Discontinuation - Emergent Signs and Symptoms (DESS) Score Over the First 2 Weeks of the Double-blind Phase | Clinician-administered 43-item assessment to evaluate discontinuation-emergent symptoms resulting from withdrawal from study treatment. Total score=sum of number of new symptoms and old (but worse) symptoms (score=1) and old and unchanged symptom, absent, or old symptom but improved (score=0); total possible range 0 to 43. Higher score=more symptoms. New symptom=any symptom that appeared within 7 days before DESS administration; old symptom=any symptom that appeared 7 days before DESS administration and continued into 7-day period. DESS calculated as 2*mean(of DESSDB Week 1, DESSDB Week 2). | Full Analysis Set (FAS): all randomized participants who had at least 1 postrandomization DESS record. Mean was adjusted for baseline DESS score and study center. | Posted | Mean | Standard Error | scores on a scale | Double-blind phase: Week 1 (Study Day 175), Week 2 (Study Day 182) |
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| Secondary | Percentage of Participants With Taper Adverse Events (AEs) in the Double-blind Phase | Any untoward medical occurrence in a patient who received study drug was considered an AE without regard to possibility of causal relationship. Taper-emergent AEs (TPAEs) are those events which occurred during the double-blind period but did not occur during the last 7 days of the on-therapy period or existed during the last 7 days and worsened in the double-blind period. | Safety population (Double-blind phase): all participants who received at least 1 dose of study treatment and were randomized into the Double-blind treatment phase. | Posted | Number | percentage of participants | Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196) |
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| Secondary | Percentage of Participants Who Were Unable to Successfully Complete Tapering of the Study Drug Because of the Number and/or Severity of Their Discontinuation Symptoms | Discontinuation symptoms may occur following abrupt cessation of serotonergic antidepressants in a minority of participants following short-term treatment of an episode of Major Depressive Disorder (MDD). The symptoms include emotional and somatic symptoms such as dizziness, nausea, and paresthesia and typically appear within 2 to 3 days of reducing the dose or stopping the antidepressant medication. Discontinuation symptoms are usually mild and resolve spontaneously within a week in the majority of patients, though a minority can have intense and prolonged symptoms. | Safety population | Posted | Number | percentage of participants | Double-blind phase: Baseline (Study Day 168) up to Week 4 (Study Day 196) |
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Events collected from the signing of the informed consent form up to 14 days after the last dose of study treatment
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | DVS SR 50 mg (Open-label Phase) | DVS SR 50 mg PO QD for 24 Weeks. | 5 | 480 | 197 | 480 | ||
| EG001 | DVS SR 50 mg (Double-blind Phase) | DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4. | 0 | 73 | 9 | 73 | ||
| EG002 | DVS SR 25 mg (Double-blind Phase) | DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4. | 0 | 140 | 18 | 140 | ||
| EG003 | Placebo (Double-blind Phase) | Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4. | 0 | 148 | 33 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Coronary artery disease | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Intentional self-injury | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Lost to Follow-up |
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| Other |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Discontinuation symptom |
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| Physician Decision |
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| Difference: DVS SR 25 mg versus DVS SR 50 mg | ANCOVA | Mean Difference (Final Values) | 0.66 | 2-Sided | 95 | -1.03 | 2.35 | Yes | Non-Inferiority or Equivalence | Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was >2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent. |
| Difference: Placebo versus DVS SR 25 mg | ANCOVA | Mean Difference (Final Values) | 0.50 | 2-Sided | 95 | -0.88 | 1.89 | Yes | Non-Inferiority or Equivalence | Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was >2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent. |
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Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4. |
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