Trial Outcomes & Findings for A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder (NCT NCT03924323)

Last Updated: 2022-11-14

Results Overview

The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including generalized anxiety disorder (GAD) in children. The PARS severity score for GAD will be assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7) each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

273 participants

Primary outcome timeframe

Baseline to Week 8

Results posted on

2022-11-14

Participant Flow

273 participants are included in the Safety Population with 136 participants being randomized to the Placebo group and 137 participants randomized to the Escitalopram group

Participant milestones

Participant milestones
Measure	Placebo Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily	Escitalopram 10 mg/Day Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period
Overall Study STARTED	136	137
Overall Study COMPLETED	117	123
Overall Study NOT COMPLETED	19	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=136 Participants Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily	Escitalopram 10 mg/Day n=137 Participants Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period	Total n=273 Participants Total of all reporting groups
Age, Continuous	12.4 years STANDARD_DEVIATION 2.6 • n=5 Participants	12.7 years STANDARD_DEVIATION 2.7 • n=7 Participants	12.6 years STANDARD_DEVIATION 2.6 • n=5 Participants
Age, Customized 7 Years to 11 Years	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Age, Customized 12 Years to 17 years	91 Participants n=5 Participants	93 Participants n=7 Participants	184 Participants n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	94 Participants n=7 Participants	187 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	31 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	114 Participants n=5 Participants	106 Participants n=7 Participants	220 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	113 Participants n=7 Participants	223 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: The modified Intent-to-treat (mITT) Population was defined as all subjects who were randomized and received at least 1 dose of study medication and had both baseline and at least 1 post-baseline primary efficacy measure (ie, PARS severity score).

Outcome measures

Outcome measures
Measure	Placebo n=117 Participants Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily	Escitalopram 10 mg/Day n=124 Participants Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period
Change in Pediatric Anxiety Rating Scale (PARS) Severity Score	-6.38 score on a scale Standard Error 0.494	-7.81 score on a scale Standard Error 0.484

SECONDARY outcome

Timeframe: Week 8

Response is defined as a 50% improvement on the PARS severity score for GAD

Outcome measures

Outcome measures
Measure	Placebo n=117 Participants Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily	Escitalopram 10 mg/Day n=124 Participants Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period
Response Rate on the PARS	39 Participants	49 Participants

SECONDARY outcome

Timeframe: Week 8

Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7)

Outcome measures

Outcome measures
Measure	Placebo n=117 Participants Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily	Escitalopram 10 mg/Day n=124 Participants Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period
Remission Rate on the PARS	22 Participants	22 Participants

SECONDARY outcome

Timeframe: Week 8

Remission rate on CGI-S at acute treatment endpoint (Week 8). Remission rate is defined as the percentage of subjects having a CGI-S score ≤2 at endpoint. CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.

Outcome measures

Outcome measures
Measure	Placebo n=118 Participants Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily	Escitalopram 10 mg/Day n=124 Participants Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period
Change on the Clinical Global Impression of Severity (CGI-S)	-1.2 score on a scale Standard Deviation 1.1	-1.3 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Week 8

Remission rate on the CGAS at acute treatment endpoint (Week 8). Functional remission is defined as CGAS \>70. The CGAS used is a 100-point scale ranging from 1 to 100, with higher scores indicating better functioning.

Outcome measures

Outcome measures
Measure	Placebo n=118 Participants Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily	Escitalopram 10 mg/Day n=124 Participants Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period
Change on the Children's Global Assessment Scale (CGAS)	16.2 score on a scale Standard Deviation 12.9	18.1 score on a scale Standard Deviation 13.1

Adverse Events

Escitalopram 10 mg/Day

Serious events: 2 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Escitalopram 10 mg/Day n=137 participants at risk Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period	Placebo n=136 participants at risk Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily
Infections and infestations ABDOMINAL ABSCESS	0.73% 1/137 • Number of events 1 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	0.00% 0/136 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).
Infections and infestations APPENDICITIS	1.5% 2/137 • Number of events 2 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	0.00% 0/136 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).
Infections and infestations KIDNEY INFECTION	0.73% 1/137 • Number of events 1 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	0.74% 1/136 • Number of events 1 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).

Other adverse events

Other adverse events
Measure	Escitalopram 10 mg/Day n=137 participants at risk Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion Escitalopram: 8-weeks of treatment followed by 1-week taper down period	Placebo n=136 participants at risk Matching oral administration of placebo once daily Placebo: Matching oral administration of inactive substance once daily
Gastrointestinal disorders NAUSEA	13.1% 18/137 • Number of events 19 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	5.1% 7/136 • Number of events 8 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).
General disorders FATIGUE	5.1% 7/137 • Number of events 8 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	7.4% 10/136 • Number of events 10 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).
Metabolism and nutrition disorders DECREASED APPETITE	7.3% 10/137 • Number of events 10 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	2.9% 4/136 • Number of events 4 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).
Nervous system disorders HEADACHE	7.3% 10/137 • Number of events 13 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	7.4% 10/136 • Number of events 12 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).
Nervous system disorders SOMNOLENCE	5.1% 7/137 • Number of events 7 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	1.5% 2/136 • Number of events 2 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).
Psychiatric disorders INSOMNIA	5.1% 7/137 • Number of events 7 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).	1.5% 2/136 • Number of events 2 • All AEs from the time the subject signed the ICF until 30 days after receiving the last dose of study drug were collected (Up to 10 weeks).

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place