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Selective Serotonin Reuptake Inhibitor

Fluoxetine for Genetic Disorder

N/A
Waitlist Available
Led By Danielle Baribeau, MD, PhD
Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, 13, 29 and 37
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effects of an oral powdered fluoxetine on a child with KCNC1-related disorder at a rehabilitation hospital. The study will last 32 to 42 weeks and will use a

Who is the study for?
This trial is for a child with KCNC1-related disorder, which is a rare genetic condition that can cause epileptic encephalopathy. The study will take place at Holland Bloorview Kids Rehabilitation Hospital and aims to improve developmental outcomes.
What is being tested?
The trial tests oral powdered fluoxetine over approximately 8 to 10 months using an ABA phase design where the patient receives placebo, then fluoxetine, and back to placebo. The exact times when active treatment starts and stops are chosen randomly but kept secret.
What are the potential side effects?
While not specified here, common side effects of fluoxetine in children may include mood changes, nervousness, insomnia, digestive issues like nausea or diarrhea, increased suicidal thoughts or behavior especially at the start of treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, 13, 29 and 37
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, 13, 29 and 37 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Motor development
Secondary study objectives
Adaptive skills
Clinical Global Impression- Improvement Scale (CGI-I)
Cognitive skills
+1 more

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635
8%
Weight Loss
8%
Stomach Pains
4%
Silliness/Feeling too happy
4%
Trouble Sleeping
4%
Nausea
4%
Menstrual Cramps
4%
Insomnia
4%
Nightmares
4%
Emotional
4%
Suicidal Behavior
4%
Lit Paper on Fire
4%
Fatigue
4%
Decreased Appetite
4%
Sweating
4%
Agitated/Restlessness
4%
Dry Mouth
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fluoxetine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Placebo-Fluoxetine-PlaceboExperimental Treatment1 Intervention
placebo (medical grade cornstarch in a gel capsule, 1 capsule daily), followed by blinded randomized cross-over moment to active fluoxetine (2.5 then 5 mg po daily), followed by blinded randomized cross-over moment back to placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
2005
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Holland Bloorview Kids Rehabilitation HospitalLead Sponsor
67 Previous Clinical Trials
14,066 Total Patients Enrolled
The Hospital for Sick ChildrenOTHER
710 Previous Clinical Trials
6,958,195 Total Patients Enrolled
Danielle Baribeau, MD, PhDPrincipal InvestigatorHolland Bloorview Kids Rehabilitation Hospital
~0 spots leftby Dec 2024
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