Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Double-Blind Treatment of Major Depressive Disorder With Vilazodone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01742832
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Vilazodone
Drug: Citalopram
Enrollment 79
Recruitment Details The Enrollment number in the Protocol Section (79) conflicts with the number of participants Started in the Participant Flow module (48) because the assessment of interested was the double-blind portion of the study. Only 48 subjects were enrolled in this phase of the study, while 79 were enrolled in the preliminary open-label phase.
Pre-assignment Details The results reported are for the double-blind phase, not the open label citalopram phase of the study.
Arm/Group Title Vilazodone Citalopram
Hide Arm/Group Description

A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Period Title: Overall Study
Started 20 28
Completed 19 23
Not Completed 1 5
Arm/Group Title Vilazodone Citalopram Total
Hide Arm/Group Description

A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Total of all reporting groups
Overall Number of Baseline Participants 19 23 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
23
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 23 participants 42 participants
31.7  (11.3) 38.6  (11.1) 35.4  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 23 participants 42 participants
Female
11
  57.9%
10
  43.5%
21
  50.0%
Male
8
  42.1%
13
  56.5%
21
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 23 participants 42 participants
19
 100.0%
23
 100.0%
42
 100.0%
1.Primary Outcome
Title Montgomery-Åsberg Depression Rating Scale (MADRS)
Hide Description

The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included.

MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used.

Time Frame Baseline and final MADRS scores during the double-blind phase.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vilazodone Citalopram
Hide Arm/Group Description:

A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Overall Number of Participants Analyzed 19 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
First Randomized Visit (Visit 8) 13.9  (5.3) 12.7  (8.4)
Second Randomized Visit (Visit 9) 14.5  (4.4) 13.2  (8.5)
Third Randomized Visit (Visit 10) 13.9  (5.1) 13.5  (8.5)
Fourth Randomized Visit (Visit 11) 13.9  (5.3) 12.7  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vilazodone, Citalopram
Comments [Not Specified]
Type of Statistical Test Other
Comments Linear repeated measures regression models were constructed to assess trends over time between groups where the dependent variable was outcome measure (MADRS score) and independent variables included visit, treatment group, visit by treatment group interaction, and any baseline variables that were significant between groups.
Statistical Test of Hypothesis P-Value 0.342
Comments P-value for linear regression assessing outcome measure (MADRS score) and treatment group.
Method Regression, Linear
Comments [Not Specified]
Time Frame The adverse events reported were during the double-blind phase of the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vilazodone Citalopram
Hide Arm/Group Description

A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.

For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.

All-Cause Mortality
Vilazodone Citalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vilazodone Citalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/23 (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 Citalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   3/19 (15.79%)   1/23 (4.35%) 
Gastrointestinal disorders     
Nausea   0/19 (0.00%)  1/23 (4.35%) 
Diarrhea   1/19 (5.26%)  0/23 (0.00%) 
General disorders     
Dry Mouth   1/19 (5.26%)  0/23 (0.00%) 
Sexual side effects   1/19 (5.26%)  0/23 (0.00%) 
Indicates events were collected by systematic assessment
The sample size was likely too small to make comments about predictors of outcome and generally the study was under-powered, which would make differences difficult to detect. The study design enrolled only non-responders into the double-blind phase.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jon Grant
Organization: University of Chicago
Phone: 773-834-1325
EMail: jongrant@uchicago.edu
Layout table for additonal information
Responsible Party: Jon Grant, University of Chicago
ClinicalTrials.gov Identifier: NCT01742832     History of Changes
Other Study ID Numbers: 2012MDDVilaz
First Submitted: December 3, 2012
First Posted: December 5, 2012
Results First Submitted: March 7, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017