Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

PHASE2RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

September 16, 2024

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Neurodevelopmental DisordersAutismAutism Spectrum DisorderFragile X SyndromeTuberous Sclerosis22Q11 Deletion Syndrome22Q11 DeletionADHDTic DisordersTourette SyndromeTourette Syndrome in ChildrenTourette Syndrome in AdolescenceADHD - Combined TypeADHD Predominantly Inattentive TypeADHD, Predominantly Hyperactive - ImpulsiveAnxietyAnxiety Disorders
Interventions
DRUG

Sertraline

Oral capsule (25mg, 50mg, 100mg, 200mg)

OTHER

Placebo

Oral placebo capsule

Trial Locations (8)

Unknown

RECRUITING

Alberta Children's Hospital - University of Calgary, Calgary

RECRUITING

University of Alberta-Glenrose, Edmonton

RECRUITING

Dalhousie University - IWK Health Centre, Halifax

NOT_YET_RECRUITING

Ste Justine Hospital - Universite de Montreal, Montreal

L8S4K1

RECRUITING

McMaster University, Hamilton

K7M8A6

NOT_YET_RECRUITING

Queen's University, Kingston

N6A 5W9

RECRUITING

University of Western Ontario, Lawson Health Research Institute, London

M4G 1R8

RECRUITING

Holland Bloorview Kids Rehabilitation Hospital, Toronto

All Listed Sponsors
collaborator

Azrieli Foundation (Funder)

UNKNOWN

collaborator

Canadian Institutes of Health Research (Funder)

UNKNOWN

collaborator

Ontario Brain Institute (Funder)

UNKNOWN

collaborator

McMaster University

OTHER

collaborator

Western University

OTHER

collaborator

Queen's University

OTHER

collaborator

University of Alberta

OTHER

collaborator

Alberta Health services

OTHER

collaborator

St. Justine's Hospital

OTHER

collaborator

Dalhousie University

OTHER

collaborator

Unity Health Toronto

OTHER

collaborator

University of Toronto

OTHER

collaborator

The Hospital for Sick Children

OTHER

collaborator

Maternal, Infant, Child and Youth Research Network (MICYRN)

UNKNOWN

lead

Holland Bloorview Kids Rehabilitation Hospital

OTHER