N/A
N=941
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
Obsessive Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01302080 ↗Enrolled (actual)
941
Serious AEs
2.3%
Results posted
Oct 2021
Primary outcome: Primary: Change From Baseline in Cognitive Function Using Trails B at Month 3 — 1.03; 1.23; 0.61; -0.39 Z-score
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- sertraline (Drug); psychotherapy (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cognitive Function Using Trails B at Month 3 |
1.03; 1.23; 0.61; -0.39; -0.09; -0.03 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Trails B at Month 6 |
-0.64; -0.65; -0.16 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Trails B at Month 12 |
-0.72; -0.22; -0.27 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Trails B at Month 18 |
-0.57; -0.65; -0.22 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Trails B at Month 24 |
-0.44; -1.08; -0.18 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Trails B at Month 30 |
-0.74; -0.61; -0.18 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Trails B at Month 36 |
-0.25; -0.13; -0.59 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 3 |
62.93; 57.67; 59.27; -2.29; 4.50; -1.88 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 6 |
-2.53; -1.54; -2.74 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 12 |
-3.12; -1.97; -2.81 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 18 |
-2.40; -1.57; -3.13 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 24 |
-3.37; -3.14; -4.16 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 30 |
-3.60; -4.39; -4.53 | — |
| PRIMARY Change From Baseline in Cognitive Function Using Metacognition Index From Behavior Rating Inventory of Executive Function (BRIEF) at Month 36 |
-3.96; -3.87; -4.62 | — |
| PRIMARY Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 3 |
65.15; 58.67; 61.88; -3.08; -1.50; -2.39 | — |
| PRIMARY Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 6 |
-4.06; -3.14; -3.62 | — |
| PRIMARY Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 12 |
-5.42; -2.44; -5.01 | — |
| PRIMARY Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 18 |
-5.21; -3.59; -4.48 | — |
| PRIMARY Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 24 |
-6.21; -5.78; -6.05 | — |
| PRIMARY Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 30 |
-6.92; -5.23; -6.53 | — |
| PRIMARY Change From Baseline in Behavioral/Emotional Regulation Using the Behavior Regulation Index From BRIEF at Month 36 |
-7.44; -7.24; -6.22 | — |
| PRIMARY Change From Baseline in Height at Month 3 |
0.31; 0.76; 0.32; 0.00; -0.03; -0.01 | — |
| PRIMARY Change From Baseline in Height at Month 6 |
-0.02; 0.07; 0.00 | — |
| PRIMARY Change From Baseline in Height at Month 12 |
-0.01; 0.06; -0.04 | — |
| PRIMARY Change From Baseline in Height at Month 18 |
-0.03; 0.00; -0.02 | — |
| PRIMARY Change From Baseline in Height at Month 24 |
0.01; -0.02; -0.02 | — |
| PRIMARY Change From Baseline in Height at Month 30 |
0.01; -0.10; 0.00 | — |
| PRIMARY Change From Baseline in Height at Month 36 |
0.00; -0.04; -0.02 | — |
| PRIMARY Change From Baseline in Weight at Month 3 |
0.58; 0.88; 0.42; 0.02; -0.22; -0.03 | — |
| PRIMARY Change From Baseline in Weight at Month 6 |
0.03; 0.01; -0.05 | — |
| PRIMARY Change From Baseline in Weight at Month 12 |
0.10; 0.06; 0.00 | — |
| PRIMARY Change From Baseline in Weight at Month 18 |
0.14; 0.07; -0.01 | — |
| PRIMARY Change From Baseline in Weight at Month 24 |
0.16; 0.15; 0.00 | — |
| PRIMARY Change From Baseline in Weight at Month 30 |
0.16; 0.11; 0.04 | — |
| PRIMARY Change From Baseline in Weight at Month 36 |
0.17; 0.17; 0.02 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) at Month 3 |
0.48; 0.79; 0.27; 0.02; -0.26; -0.03 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) at Month 6 |
0.04; -0.03; -0.06 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) at Month 12 |
0.13; 0.06; 0.04 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) at Month 18 |
0.18; 0.07; -0.04 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) at Month 24 |
0.17; 0.20; -0.01 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) at Month 30 |
0.16; 0.15; 0.03 | — |
| PRIMARY Change From Baseline in Body Mass Index (BMI) at Month 36 |
0.17; 0.21; 0.01 | — |
| PRIMARY Primary: Number of Participants With Tanner Staging Evaluation at Baseline: All Males |
122; 58; 53; 20; 45; 17 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 3: All Males |
94; 1; 42; 40; 0; 10 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 6: All Males |
75; 6; 36; 44; 2; 11 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 12: All Males |
55; 7; 30; 37; 2; 11 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 18: All Males |
39; 9; 20; 31; 5; 11 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 24: All Males |
32; 7; 13; 27; 9; 12 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 30: All Males |
23; 5; 10; 18; 7; 8 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 36: All Males |
18; 6; 7; 18; 4; 12 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Baseline: All Females |
81; 1; 39; 40; 0; 21 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 3: All Females |
59; 1; 30; 37; 0; 13 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 6: All Females |
43; 1; 22; 31; 4; 13 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 12: All Females |
27; 5; 9; 27; 2; 15 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 18: All Females |
17; 4; 9; 14; 2; 14 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 24: All Females |
13; 2; 8; 15; 3; 10 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 30: All Females |
10; 1; 3; 15; 2; 9 | — |
| PRIMARY Number of Participants With Tanner Staging Evaluation at Month 36: All Females |
9; 0; 2; 9; 2; 9 | — |
| SECONDARY Number of Participants in Each Category of Clinical Global Impression-Improvement (CGI-I) Scale at Month 3, 6, 12, 18, 24, 30 and 36 |
77; 0; 17; 223; 0; 51 | — |
| SECONDARY Number of Participants in Each Category of Clinical Global Impression-Tolerability (CGI-T) Scale at Month 3, 6, 12, 18, 24, 30 and 36 |
274; 0; 25; 123; 0; 18 | — |
| SECONDARY Number of Participants Who Were Responders According to Clinical Global Impression-Effectiveness (CGI-E) Scale at Month 3, 6, 12, 18, 24, 30 and 36 |
296; 1; 55; 309; 14; 72 | — |
| SECONDARY Number of Participants in Each Category of Clinical Global Impression-Severity (CGI-S) Scale at Baseline, Month 3, 6, 12, 18, 24, 30 and 36 |
21; 0; 29; 28; 0; 17 | — |
| SECONDARY Change From Baseline in Child Global Assessment Scale (CGAS) at Month 3, 6, 12, 18, 24, 30 and 36 |
55.80; 56.67; 59.86; 6.58; -7.67; 4.61 | — |
| SECONDARY Change From Baseline in General Health and Social Functioning Using the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) Total Score at Month 3, 6, 12, 18, 24, 30 and 36 |
10.51; 8.33; 9.19; -2.75; 4.33; -2.05 | — |
Summary
To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.
Eligibility Criteria
Inclusion Criteria
- Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.
Exclusion Criteria
- Psychotic at study entry
- Diagnosis of bipolar disorder
- Diagnosis of schizoaffective or schizophrenia
- Anorexia
- Bulimia or eating disorder not otherwise specified (NOS)
- Autism
- Pervasive developmental disorder
- High risk of suicide within 2 weeks of initiating study treatment
- Significant mental retardation
- Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant
Data sourced from ClinicalTrials.gov (NCT01302080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.