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Selective Serotonin Reuptake Inhibitor

Fluoxetine for Rare Diseases

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1, 13, 29 and 37

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Motor development

Secondary outcome measures

Adaptive skills

Clinical Global Impression- Improvement Scale (CGI-I)

Cognitive skills

+1 more

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635

Stomach Pains

Weight Loss

Nausea

Trouble Sleeping

Insomnia

Nightmares

Menstrual Cramps

Silliness/Feeling too happy

Emotional

Suicidal Behavior

Lit Paper on Fire

Fatigue

Decreased Appetite

Sweating

Agitated/Restlessness

Dry Mouth

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fluoxetine

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Holland Bloorview Kids Rehabilitation HospitalLead Sponsor

67 Previous Clinical Trials

14,073 Total Patients Enrolled

The Hospital for Sick ChildrenOTHER

691 Previous Clinical Trials

6,945,613 Total Patients Enrolled

Danielle Baribeau, MD, PhDPrincipal InvestigatorHolland Bloorview Kids Rehabilitation Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"As per clinicaltrials.gov, the present trial is not in an active recruitment phase. Its online listing was first made available on January 17th, 2024, with updates last recorded on March 25th of the same year. Although this specific research endeavor is currently inactive in seeking participants, it's worth noting that there are presently 62 alternative clinical trials actively enrolling patients at this time."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"Throughout the study period, spanning roughly 42 weeks from randomization, researchers will focus primarily on documenting any Treatment-Emergent Adverse Events to assess safety and tolerability. Secondary objectives involve evaluating cognitive abilities via Mullen Scales of Early Learning, adaptive skills using Vineland Adaptive Behavior Scale, and overall developmental progress through Clinical Global Impression- Improvement Scale (CGI-I) as per clinician assessment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluoxetine in KCNC1-related Disorder

2024. "Fluoxetine in KCNC1-related Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06341127.

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