Trial Outcomes & Findings for Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22) (NCT NCT02372799)

Last Updated: 2019-10-01

Results Overview

The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

473 participants

Primary outcome timeframe

From Baseline to Week 8

Results posted on

2019-10-01

Participant Flow

Randomization and treatment assignment were based on a randomization scheme prepared by Allergan Biostatistics prior to the start of the study

Participant milestones

Participant milestones
Measure	Placebo Dose-matched placebo tablets or capsules, oral administration, once per day.	Vilazodone Vilazodone tablets 15-30 mg. Oral administration, once per day.	Fluoxetine Fluoxetine capsules 20 mg. Oral administration, once per day.
Treatment Period STARTED	186	187	97
Treatment Period COMPLETED	152	155	82
Treatment Period NOT COMPLETED	34	32	15
Down-taper Period STARTED	152	159	82
Down-taper Period COMPLETED	151	157	80
Down-taper Period NOT COMPLETED	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Dose-matched placebo tablets or capsules, oral administration, once per day.	Vilazodone Vilazodone tablets 15-30 mg. Oral administration, once per day.	Fluoxetine Fluoxetine capsules 20 mg. Oral administration, once per day.
Treatment Period Adverse Event	3	10	6
Treatment Period Insufficient therapeutic response	2	2	0
Treatment Period Withdrawal by Subject	10	10	2
Treatment Period Lost to Follow-up	11	5	3
Treatment Period Protocol Violation	3	0	0
Treatment Period Non-compliance with study drug	4	4	4
Treatment Period Miscellaneous Reasons	1	1	0
Down-taper Period Lost to Follow-up	1	2	2

Baseline Characteristics

The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=186 Participants Dose-matched placebo tablets or capsules, oral administration, once per day.	Vilazodone n=187 Participants Vilazodone tablets 15-30 mg. Oral administration, once per day.	Fluoxetine n=97 Participants Fluoxetine capsules 20 mg. Oral administration, once per day.	Total n=470 Participants Total of all reporting groups
Age, Continuous	13 Years STANDARD_DEVIATION 2.9 • n=186 Participants	13 Years STANDARD_DEVIATION 2.9 • n=187 Participants	13.2 Years STANDARD_DEVIATION 2.8 • n=97 Participants	13 Years STANDARD_DEVIATION 2.9 • n=470 Participants
Age, Customized 7-11	61 Participants n=186 Participants	55 Participants n=187 Participants	30 Participants n=97 Participants	146 Participants n=470 Participants
Age, Customized 12-17	125 Participants n=186 Participants	132 Participants n=187 Participants	67 Participants n=97 Participants	324 Participants n=470 Participants
Sex: Female, Male Female	106 Participants n=186 Participants	126 Participants n=187 Participants	51 Participants n=97 Participants	283 Participants n=470 Participants
Sex: Female, Male Male	80 Participants n=186 Participants	61 Participants n=187 Participants	46 Participants n=97 Participants	187 Participants n=470 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=186 Participants	25 Participants n=187 Participants	12 Participants n=97 Participants	64 Participants n=470 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	159 Participants n=186 Participants	162 Participants n=187 Participants	85 Participants n=97 Participants	406 Participants n=470 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=186 Participants	0 Participants n=187 Participants	0 Participants n=97 Participants	0 Participants n=470 Participants
Race/Ethnicity, Customized White	118 Participants n=186 Participants	121 Participants n=187 Participants	60 Participants n=97 Participants	299 Participants n=470 Participants
Race/Ethnicity, Customized Black or African American	57 Participants n=186 Participants	58 Participants n=187 Participants	30 Participants n=97 Participants	145 Participants n=470 Participants
Race/Ethnicity, Customized Asian	5 Participants n=186 Participants	1 Participants n=187 Participants	1 Participants n=97 Participants	7 Participants n=470 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=186 Participants	0 Participants n=187 Participants	0 Participants n=97 Participants	0 Participants n=470 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=186 Participants	2 Participants n=187 Participants	0 Participants n=97 Participants	3 Participants n=470 Participants
Race/Ethnicity, Customized Other	5 Participants n=186 Participants	5 Participants n=187 Participants	5 Participants n=97 Participants	15 Participants n=470 Participants
Race/Ethnicity, Customized Missing	0 Participants n=186 Participants	0 Participants n=187 Participants	1 Participants n=97 Participants	1 Participants n=470 Participants
Weight	59.13 kg STANDARD_DEVIATION 24.29 • n=186 Participants	61.35 kg STANDARD_DEVIATION 24.79 • n=187 Participants	59.38 kg STANDARD_DEVIATION 21.14 • n=97 Participants	60.07 kg STANDARD_DEVIATION 23.86 • n=470 Participants
Body Mass Index (BMI)	23.31 kg/m2 STANDARD_DEVIATION 6.85 • n=186 Participants	24.25 kg/m2 STANDARD_DEVIATION 7.58 • n=187 Participants	23.48 kg/m2 STANDARD_DEVIATION 6.66 • n=97 Participants	23.72 kg/m2 STANDARD_DEVIATION 7.11 • n=470 Participants
CDRS-R total score	57.3 units on a scale STANDARD_DEVIATION 9.2 • n=182 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.	58.3 units on a scale STANDARD_DEVIATION 9.2 • n=186 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.	58 units on a scale STANDARD_DEVIATION 8.8 • n=97 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.	57.8 units on a scale STANDARD_DEVIATION 9.1 • n=465 Participants • The CDRS-R total score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.
CGI-S score	4.6 Units on a Scale STANDARD_DEVIATION 0.6 • n=182 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.	4.7 Units on a Scale STANDARD_DEVIATION 0.6 • n=186 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.	4.6 Units on a Scale STANDARD_DEVIATION 0.6 • n=97 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.	4.6 Units on a Scale STANDARD_DEVIATION 0.6 • n=465 Participants • The CGI-S score is provided at baseline for the Intent to Treat study population, which comprises the 465 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.

PRIMARY outcome

Timeframe: From Baseline to Week 8

Population: The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score.

Outcome measures

Outcome measures
Measure	Placebo n=182 Participants Dose-matched placebo tablets or capsules, oral administration, once per day.	Vilazodone n=186 Participants Vilazodone tablets 15-30 mg. Oral administration, once per day.	Fluoxetine n=97 Participants Fluoxetine capsules 20 mg. Oral administration, once per day.
Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	-20.32 units on a scale Standard Error 0.983	-20.72 units on a scale Standard Error 0.977	-22.71 units on a scale Standard Error 1.320

SECONDARY outcome

Timeframe: From Baseline to Week 8

The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.

Outcome measures

Outcome measures
Measure	Placebo n=182 Participants Dose-matched placebo tablets or capsules, oral administration, once per day.	Vilazodone n=186 Participants Vilazodone tablets 15-30 mg. Oral administration, once per day.	Fluoxetine n=97 Participants Fluoxetine capsules 20 mg. Oral administration, once per day.
Change in Clinical Global Impressions-Severity (CGI-S) Score	-1.52 units on a scale Standard Error 0.097	-1.57 units on a scale Standard Error 0.096	-1.72 units on a scale Standard Error 0.130

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 54 other events

Deaths: 0 deaths

Vilazodone

Serious events: 0 serious events

Other events: 97 other events

Deaths: 0 deaths

Fluoxetine

Serious events: 6 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=186 participants at risk Dose-matched placebo tablets or capsules, oral administration, once per day.	Vilazodone n=187 participants at risk Vilazodone tablets 15-30 mg. Oral administration, once per day.	Fluoxetine n=97 participants at risk Fluoxetine capsules 20 mg. Oral administration, once per day.
Infections and infestations Croup infectious	0.54% 1/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	0.00% 0/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	0.00% 0/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Psychiatric disorders Depressive symptom	0.00% 0/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	0.00% 0/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	1.0% 1/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Psychiatric disorders Hallucination, auditory	0.00% 0/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	0.00% 0/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	1.0% 1/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Injury, poisoning and procedural complications Overdose	0.00% 0/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	0.00% 0/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	1.0% 1/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Psychiatric disorders Suicidal ideation	0.00% 0/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	0.00% 0/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	3.1% 3/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.

Other adverse events

Other adverse events
Measure	Placebo n=186 participants at risk Dose-matched placebo tablets or capsules, oral administration, once per day.	Vilazodone n=187 participants at risk Vilazodone tablets 15-30 mg. Oral administration, once per day.	Fluoxetine n=97 participants at risk Fluoxetine capsules 20 mg. Oral administration, once per day.
Gastrointestinal disorders Nausea	7.0% 13/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	21.4% 40/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	6.2% 6/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Gastrointestinal disorders Vomiting	3.8% 7/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	12.8% 24/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	4.1% 4/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Gastrointestinal disorders Diarrhoea	3.2% 6/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	8.6% 16/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	2.1% 2/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Gastrointestinal disorders Abdominal pain upper	3.2% 6/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	7.0% 13/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	4.1% 4/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Infections and infestations Upper respiratory tract infection	2.7% 5/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	3.2% 6/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	5.2% 5/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Nervous system disorders Headache	16.7% 31/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	12.8% 24/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	10.3% 10/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Nervous system disorders Somnolence	2.2% 4/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	6.4% 12/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	2.1% 2/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Nervous system disorders Dizziness	2.7% 5/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	5.3% 10/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	2.1% 2/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.
Psychiatric disorders Insomnia	1.6% 3/186 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	5.3% 10/187 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.	6.2% 6/97 • Adverse event data was collected from the participant's signing of the Informed Consent Forum until 30 days after the last does of study treatment, spanning a period of 10 to 13 weeks.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All data generated in this study are the property of the sponsor. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and the sponsor and will follow sponsor's standard operating procedures on publications.
Publication restrictions are in place

Restriction type: OTHER