Trial Outcomes & Findings for A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD) (NCT NCT00644358)

Last Updated: 2017-09-25

Results Overview

An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of study medication or was present at, or before, the day of the first dose of study medication and increased in severity during the treatment period. AEs included abnormal clinically significant findings for laboratory parameters, physical examinations, vital signs, weight, electrocardiograms (ECGs), the Change in Sexual Functioning Questionnaire (CSFQ), ophthalmologic exams and the Columbia-Suicide Severity Rating Scale (C-SSRS).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

616 participants

Primary outcome timeframe

From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)

Results posted on

2017-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Vilazodone Vilazodone titrated up to 40 milligrams (mg)/day for 1 year.
Overall Study STARTED	616
Overall Study COMPLETED	254
Overall Study NOT COMPLETED	362

Reasons for withdrawal

Reasons for withdrawal
Measure	Vilazodone Vilazodone titrated up to 40 milligrams (mg)/day for 1 year.
Overall Study Adverse Event	124
Overall Study Lost to Follow-up	105
Overall Study Consent Withdrawal	64
Overall Study Lack of Effectiveness	39
Overall Study Protocol Violation	5
Overall Study Noncompliance	14
Overall Study Other Unspecified	11

Baseline Characteristics

A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vilazodone n=599 Participants Vilazodone titrated up to 40 mg/day for 1 year.
Age, Continuous	42.8 years STANDARD_DEVIATION 12.47 • n=5 Participants
Sex: Female, Male Female	407 Participants n=5 Participants
Sex: Female, Male Male	192 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	545 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	103 Participants n=5 Participants
Race (NIH/OMB) White	479 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Height	168.4 cm STANDARD_DEVIATION 9.62 • n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)

Population: Safety population consisted of enrolled participants who took at least 1 dose of study drug and had at least 1 post-baseline safety measurement.

Outcome measures

Outcome measures
Measure	Vilazodone n=599 Participants Vilazodone titrated up to 40 mg/day for 1 year.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	562 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

Population: Effectiveness Population consisted of all participants who took at least one dose, and had at least one post-baseline efficacy endpoint measurement. The number analyzed for each category row is the number of participants with available data at the given time-point.

The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Participants were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.

Outcome measures

Outcome measures
Measure	Vilazodone n=596 Participants Vilazodone titrated up to 40 mg/day for 1 year.
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 28	-21.6 score on a scale Standard Deviation 7.99
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Baseline	29.9 score on a scale Standard Deviation 4.45
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 1	-4.7 score on a scale Standard Deviation 5.38
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 2	-9.3 score on a scale Standard Deviation 6.72
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 3	-13.0 score on a scale Standard Deviation 7.76
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 4	-14.9 score on a scale Standard Deviation 7.99
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 6	-17.1 score on a scale Standard Deviation 8.28
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 8	-18.5 score on a scale Standard Deviation 8.38
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 12	-19.9 score on a scale Standard Deviation 8.31
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 16	-20.6 score on a scale Standard Deviation 8.31
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 20	-21.1 score on a scale Standard Deviation 8.39
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 24	-21.7 score on a scale Standard Deviation 7.81
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 32	-21.9 score on a scale Standard Deviation 8.26
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 36	-22.1 score on a scale Standard Deviation 7.89
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 40	-22.7 score on a scale Standard Deviation 7.33
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 44	-21.9 score on a scale Standard Deviation 8.12
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 48	-22.5 score on a scale Standard Deviation 7.92
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Week 52	-22.8 score on a scale Standard Deviation 7.89
Change Form Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score Change from Baseline at Early Termination	-10.9 score on a scale Standard Deviation 9.78

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

The CGI-S is a clinician-rated scale that measures global severity of illness at a given point in time using a 7-point scale where 1=normal, not at all ill, and 7=among the most severely ill. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Vilazodone n=596 Participants Vilazodone titrated up to 40 mg/day for 1 year.
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Baseline	4.3 score on a scale Standard Deviation 0.52
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 1	-0.3 score on a scale Standard Deviation 0.57
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 2	-0.7 score on a scale Standard Deviation 0.83
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 3	-1.1 score on a scale Standard Deviation 1.04
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 4	-1.4 score on a scale Standard Deviation 1.12
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 6	-1.7 score on a scale Standard Deviation 1.18
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 8	-1.9 score on a scale Standard Deviation 1.21
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 12	-2.1 score on a scale Standard Deviation 1.18
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 16	-2.3 score on a scale Standard Deviation 1.13
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 20	-2.4 score on a scale Standard Deviation 1.15
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 24	-2.4 score on a scale Standard Deviation 1.09
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 28	-2.4 score on a scale Standard Deviation 1.09
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 32	-2.5 score on a scale Standard Deviation 1.11
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 36	-2.5 score on a scale Standard Deviation 1.13
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 40	-2.5 score on a scale Standard Deviation 1.05
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 44	-2.4 score on a scale Standard Deviation 1.12
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 48	-2.5 score on a scale Standard Deviation 1.08
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Week 52	-2.6 score on a scale Standard Deviation 1.13
Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score Change from Baseline at Early Termination	-1.0 score on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: Weeks 1, 2, 3, 4, 6 ,8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52/Early Termination

The CGI-I is a clinician-rated scale for assessing improvement of a patient's condition, using a 7-point scale where 1=very much improved (best) and 7=very much worse.

Outcome measures

Outcome measures
Measure	Vilazodone n=596 Participants Vilazodone titrated up to 40 mg/day for 1 year.
Clinical Global Impression - Improvement (CGI-I) Score Week 16	1.6 score on a scale Standard Deviation 0.90
Clinical Global Impression - Improvement (CGI-I) Score Week 20	1.5 score on a scale Standard Deviation 0.84
Clinical Global Impression - Improvement (CGI-I) Score Week 24	1.5 score on a scale Standard Deviation 0.75
Clinical Global Impression - Improvement (CGI-I) Score Week 1	3.5 score on a scale Standard Deviation 0.67
Clinical Global Impression - Improvement (CGI-I) Score Week 2	3.0 score on a scale Standard Deviation 0.85
Clinical Global Impression - Improvement (CGI-I) Score Week 3	2.5 score on a scale Standard Deviation 0.94
Clinical Global Impression - Improvement (CGI-I) Score Week 4	2.3 score on a scale Standard Deviation 0.94
Clinical Global Impression - Improvement (CGI-I) Score Week 6	2.0 score on a scale Standard Deviation 0.92
Clinical Global Impression - Improvement (CGI-I) Score Week 8	1.9 score on a scale Standard Deviation 0.93
Clinical Global Impression - Improvement (CGI-I) Score Week 12	1.7 score on a scale Standard Deviation 0.93
Clinical Global Impression - Improvement (CGI-I) Score Week 28	1.5 score on a scale Standard Deviation 0.79
Clinical Global Impression - Improvement (CGI-I) Score Week 32	1.5 score on a scale Standard Deviation 0.83
Clinical Global Impression - Improvement (CGI-I) Score Week 36	1.5 score on a scale Standard Deviation 0.78
Clinical Global Impression - Improvement (CGI-I) Score Week 40	1.4 score on a scale Standard Deviation 0.74
Clinical Global Impression - Improvement (CGI-I) Score Week 44	1.5 score on a scale Standard Deviation 0.86
Clinical Global Impression - Improvement (CGI-I) Score Week 48	1.4 score on a scale Standard Deviation 0.74
Clinical Global Impression - Improvement (CGI-I) Score Week 52	1.4 score on a scale Standard Deviation 0.75
Clinical Global Impression - Improvement (CGI-I) Score Early Termination	2.9 score on a scale Standard Deviation 1.18

Adverse Events

Vilazodone

Serious events: 23 serious events

Other events: 497 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vilazodone n=599 participants at risk Vilazodone titrated up to 40 mg/day for 1 year.
Gastrointestinal disorders Duodenal stenosis	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
General disorders Chest discomfort	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
General disorders Chest pain	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
General disorders Pyrexia	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Hepatobiliary disorders Cholecystitis	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Hepatobiliary disorders Gallbladder disorder	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Infections and infestations Abdominal wall abscess	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Infections and infestations Enterocolitis infectious	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Infections and infestations Gastroenteritis	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Infections and infestations Pneumonia	0.33% 2/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Injury, poisoning and procedural complications Overdose	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Injury, poisoning and procedural complications Skin laceration	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Investigations Bronchoscopy	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Metabolism and nutrition disorders Dehydration	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Metabolism and nutrition disorders Hypokalaemia	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Metabolism and nutrition disorders Hyponatraemia	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Metabolism and nutrition disorders Obesity	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Nervous system disorders Serotonin syndrome	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Nervous system disorders Syncope	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Nervous system disorders Transient ischaemic attack	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Psychiatric disorders Panic attack	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Psychiatric disorders Suicidal ideation	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Psychiatric disorders Suicide attempt	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Renal and urinary disorders Renal failure acute	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Reproductive system and breast disorders Endometriosis	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Reproductive system and breast disorders Menometrorrhagia	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Vascular disorders Deep vein thrombosis	0.17% 1/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)

Other adverse events

Other adverse events
Measure	Vilazodone n=599 participants at risk Vilazodone titrated up to 40 mg/day for 1 year.
Gastrointestinal disorders Diarrhoea	35.7% 214/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Gastrointestinal disorders Dry mouth	11.0% 66/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Gastrointestinal disorders Nausea	31.6% 189/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Gastrointestinal disorders Vomiting	7.3% 44/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
General disorders Fatigue	7.7% 46/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Infections and infestations Nasopharyngitis	7.5% 45/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Infections and infestations Upper respiratory tract infection	13.7% 82/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Infections and infestations Urinary tract infection	5.8% 35/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Investigations Weight increased	9.5% 57/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Metabolism and nutrition disorders Increased appetite	9.0% 54/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Musculoskeletal and connective tissue disorders Back pain	5.5% 33/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Nervous system disorders Dizziness	10.7% 64/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Nervous system disorders Headache	20.0% 120/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Nervous system disorders Somnolence	10.7% 64/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Psychiatric disorders Abnormal dreams	10.4% 62/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Psychiatric disorders Anxiety	6.0% 36/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)
Psychiatric disorders Insomnia	13.0% 78/599 • From first dose of study medication and up to 30 days after the last dose of study medication (Up to 13 months)

Additional Information

Therapeutic Area Head

Allergan, Inc.

Phone: 1-877-277-8566

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER