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Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone

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ClinicalTrials.gov Identifier: NCT02015546
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : February 9, 2015
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Major Depressive Disorder (MDD)
Intervention Drug: Vilazodone
Enrollment 70
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 23 21 26
Completed 20 19 22
Not Completed 3 2 4
Reason Not Completed
Withdrawal by Subject             1             1             1
Screem Failure             2             1             3
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg Total
Hide Arm/Group Description

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 23 21 26 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 26 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
21
 100.0%
26
 100.0%
70
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 26 participants 70 participants
Female
14
  60.9%
14
  66.7%
17
  65.4%
45
  64.3%
Male
9
  39.1%
7
  33.3%
9
  34.6%
25
  35.7%
1.Primary Outcome
Title Change in Total MADRS Scores From Baseline to Week 8
Hide Description 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.
Time Frame Baseline, Week 8
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-24.95  (10) -18.95  (9.71) -23.89  (6.75)
2.Primary Outcome
Title Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)
Hide Description

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.

Time Frame Baseline, week 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.597  (1.201) -4.002  (1.211) -4.120  (0.992)
3.Primary Outcome
Title Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)
Hide Description 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.
Time Frame Baseline, Weeks 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.640  (1.274) -3.750  (1.188) -3.741  (1.267)
4.Secondary Outcome
Title Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
Hide Description 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.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.937  (1.278) -1.856  (0.494) -1.013  (0.214)
5.Secondary Outcome
Title Change in Sheehan Disability Scale (SDS)
Hide Description 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.
Time Frame Baseline, 8 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.72  (1.341) -3.617  (1.543) -3.364  (1.333)
6.Secondary Outcome
Title Change in Clinical Global Impression-Improvement (CGI-I) Scale
Hide Description 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.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.647  (1.114) -1.777  (1.06) -1.529  (0.624)
7.Secondary Outcome
Title Change in Clinical Global Impression-Severity (CGI-S) Scale
Hide Description 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.
Time Frame Baseline, 8 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.176  (1.161) -1.944  (0.898) -2.058  (0.937)
8.Secondary Outcome
Title MADRS Response
Hide Description Number of subjects who had a ≥ 50% decrease in MADRS score from baseline
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Measure Type: Number
Unit of Measure: participants
14 15 15
9.Secondary Outcome
Title MADRS Remission
Hide Description MADRS remission is defined as MADRS score < 10
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 20 19 22
Measure Type: Number
Unit of Measure: participants
9 14 14
Time Frame Adverse events were collected for participants who took at least one dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vilazodone 10mg Vilazodone 20mg Vilazodone 40mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/20 (35.00%)   19/19 (100.00%)   22/22 (100.00%) 
Gastrointestinal disorders       
Dry Mouth *  7/20 (35.00%)  19/19 (100.00%)  22/22 (100.00%) 
Nausea *  0/20 (0.00%)  4/19 (21.05%)  6/22 (27.27%) 
Diarrhea *  0/20 (0.00%)  0/19 (0.00%)  5/22 (22.73%) 
General disorders       
Weight Gain *  0/20 (0.00%)  14/19 (73.68%)  22/22 (100.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Ashwin Patkar
Organization: Duke University Medical Center
Phone: 919-681-0613
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02015546     History of Changes
Other Study ID Numbers: Pro00036210
First Submitted: October 8, 2013
First Posted: December 19, 2013
Results First Submitted: December 30, 2014
Results First Posted: February 9, 2015
Last Update Posted: April 16, 2015