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This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10 mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S. FDA for the treatment of major depressive disorder in adults. The purpose of this study is to evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent the recurrence of depression, for the purposes of this study it is considered investigational. The word "investigational" means that the study drug is still being tested in research studies and has not been approved for this use by the FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilazodone 10mg | Experimental | Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial) |
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| Vilazodone 20mg | Experimental | vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial) |
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| Vilazodone 40mg | Experimental | vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilazodone | Drug | All subjects will receive Vilazodone at 10, 20 or 40mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Total MADRS Scores From Baseline to Week 8 | The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms. | Baseline, Week 8 |
| Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS) | DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary. Total possible range is 0 to 172. A higher score indicates more symptoms. | Baseline, week 9 |
| Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX) | The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. | Baseline, Weeks 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores | HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety. | Baseline, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashwin A Patkar, MD | Duke University Health Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center / Civitan Building | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26693034 | Derived | Rele S, Millet R, Kim S, Paik JW, Kim S, Masand PS, Patkar AA. An 8-Week Randomized, Double-Blind Trial Comparing Efficacy, Safety, and Tolerability of 3 Vilazodone Dose-Initiation Strategies Following Switch From SSRIs and SNRIs in Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Aug 6;17(4):10.4088/PCC.14m01734. doi: 10.4088/PCC.14m01734. eCollection 2015. |
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All subjects who signed a consent form were randomized to a treatment group. 6 subjects were screen failures and did not begin taking the study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vilazodone 10mg | Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial) Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg. |
| FG001 | Vilazodone 20mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Change in Sheehan Disability Scale (SDS) | The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. | Baseline, 8 week |
| Change in Clinical Global Impression-Improvement (CGI-I) Scale | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Baseline, Week 8 |
| Change in Clinical Global Impression-Severity (CGI-S) Scale | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | Baseline, 8 week |
| MADRS Response | Number of subjects who had a ≥ 50% decrease in MADRS score from baseline | Baseline, Week 8 |
| MADRS Remission | MADRS remission is defined as MADRS score < 10 | Week 8 |
vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)
Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg.
| FG002 | Vilazodone 40mg | vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial. Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vilazodone 10mg | Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial) Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg. |
| BG001 | Vilazodone 20mg | vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial) Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg. |
| BG002 | Vilazodone 40mg | vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial. Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total MADRS Scores From Baseline to Week 8 | The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8 |
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| Primary | Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS) | DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary. Total possible range is 0 to 172. A higher score indicates more symptoms. | Posted | Mean | Standard Deviation | units on a scale | Baseline, week 9 |
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| Primary | Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX) | The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 8 |
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| Secondary | Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores | HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 weeks |
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| Secondary | Change in Sheehan Disability Scale (SDS) | The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 week |
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| Secondary | Change in Clinical Global Impression-Improvement (CGI-I) Scale | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 8 |
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| Secondary | Change in Clinical Global Impression-Severity (CGI-S) Scale | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 week |
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| Secondary | MADRS Response | Number of subjects who had a ≥ 50% decrease in MADRS score from baseline | Posted | Number | participants | Baseline, Week 8 |
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| Secondary | MADRS Remission | MADRS remission is defined as MADRS score < 10 | Posted | Number | participants | Week 8 |
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Adverse events were collected for participants who took at least one dose.
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vilazodone 10mg | Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial) Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg. | 0 | 20 | 7 | 20 | ||
| EG001 | Vilazodone 20mg | vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial) Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg. | 0 | 19 | 19 | 19 | ||
| EG002 | Vilazodone 40mg | vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial. Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg. | 0 | 22 | 22 | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Weight Gain | General disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashwin Patkar | Duke University Medical Center | 919-681-0613 | ashwin.patkar@duke.edu |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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