Trial · NCT01608295
Vilazodone for Treatment of Geriatric Depression
NCT01608295, Phase 4, Completed, University of California, Los Angeles; results first posted 2017-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vilazodone for Treatment of Geriatric Depression. Trials, record NCT01608295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01608295
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vilazodone for Treatment of Geriatric Depression
- NCT number
- NCT01608295
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 65 participants, actual
- Lead sponsor
- University of California, Los Angeles
- Conditions
- Major Depressive Disorder
- Interventions
- Vilazodone; Viibryd, Paroxetine; Paxil
- First posted
- 2012-05-31
- Last updated
- 2018-05-11
- Results first posted
- 2017-05-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hamilton Depression Rating Scale (HDRS) | Baseline and 12 weeks | The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. |
| Secondary | UKU Side-effect Profile | Each visit for 12 weeks | Number of participants with each side-effect event. |
| Secondary | Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test | Baseline and Final Visit | The The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points. |
| Secondary | Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks) | Baseline and Final Visit | Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hamilton Depression Rating Scale (HDRS) | Baseline and 12 weeks | units on a scale | MEAN | |
| SECONDARY | UKU Side-effect Profile | Each visit for 12 weeks | participants | NUMBER | |
| SECONDARY | Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test | Baseline and Final Visit | units on a scale | MEAN | |
| SECONDARY | Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks) | Baseline and Final Visit | The Arms/Groups are not combined, but results are presented as a ratio of Vilazodone/Paroxetine. | RNA expression units | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | Vilazodone; Viibryd | HDRS Baseline | 17.2 | Standard Deviation 3.7 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | Paroxetine; Paxil | HDRS Baseline | 16.6 | Standard Deviation 4.1 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | Vilazodone; Viibryd | HDRS Final Visit | 7.6 | Standard Deviation 4.8 | units on a scale |
| Hamilton Depression Rating Scale (HDRS) | Paroxetine; Paxil | HDRS Final Visit | 7.5 | Standard Deviation 5.9 | units on a scale |
| UKU Side-effect Profile | Vilazodone; Viibryd | Concentration Difficulties | 3 | participants | |
| UKU Side-effect Profile | Paroxetine; Paxil | Concentration Difficulties | 0 | participants | |
| UKU Side-effect Profile | Vilazodone; Viibryd | Sedation | 1 | participants | |
| UKU Side-effect Profile | Paroxetine; Paxil | Sedation | 3 | participants | |
| UKU Side-effect Profile | Vilazodone; Viibryd | Increased dream activity | 3 | participants | |
| UKU Side-effect Profile | Paroxetine; Paxil | Increased dream activity | 3 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vilazodone; Viibryd | 26 | |
| Overall Study | STARTED | Paroxetine; Paxil | 30 | |
| Overall Study | COMPLETED | Vilazodone; Viibryd | 20 | |
| Overall Study | COMPLETED | Paroxetine; Paxil | 25 | |
| Overall Study | NOT COMPLETED | Vilazodone; Viibryd | 6 | |
| Overall Study | NOT COMPLETED | Paroxetine; Paxil | 5 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Reduced salivation | Gastrointestinal disorders | Vilazodone; Viibryd | 3 | 26 | |
| other | Reduced salivation | Gastrointestinal disorders | Paroxetine; Paxil | 1 | 30 | |
| other | Concentration Difficulties | Psychiatric disorders | Vilazodone; Viibryd | 3 | 26 | |
| other | Concentration Difficulties | Psychiatric disorders | Paroxetine; Paxil | 0 | 30 | |
| other | Sedation | Nervous system disorders | Vilazodone; Viibryd | 1 | 26 | |
| other | Sedation | Nervous system disorders | Paroxetine; Paxil | 3 | 30 | |
| other | Increased Dream Activity | Nervous system disorders | Vilazodone; Viibryd | 3 | 26 | |
| other | Increased Dream Activity | Nervous system disorders | Paroxetine; Paxil | 3 | 30 | |
| other | Diarrhea | Gastrointestinal disorders | Vilazodone; Viibryd | 3 | 26 | |
| other | Diarrhea | Gastrointestinal disorders | Paroxetine; Paxil | 1 | 30 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vilazodone; Viibryd | ||
| Total, all-cause mortality | Paroxetine; Paxil | ||
| Total, other adverse events | Vilazodone; Viibryd | 19 | 26 |
| Total, other adverse events | Paroxetine; Paxil | 16 | 30 |
| Total, serious adverse events | Vilazodone; Viibryd | 0 | 26 |
| Total, serious adverse events | Paroxetine; Paxil | 0 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vilazodone; Viibryd vs Paroxetine; Paxil: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Complex Figure Copy and Recall | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01608295
GET https://conductscience.org/api/trials/v1/NCT01608295/results?page=2