Fluoxetine for Down Syndrome

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Lurie Center for Autism, Lexington, MA
Down Syndrome+3 More
Fluoxetine - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of the study is to do a preliminary assessment of whether fluoxetine is effective, safe, and tolerable for the treatment of depression in adults with Down syndrome.

Eligible Conditions

  • Down Syndrome
  • Depression

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Down Syndrome

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, Week 4, Week 8, Week 12, Week 16

Week 16
Mean 16-Week Change in Glasgow Depression Scale for people with a Learning Disability (GDS-LD) Total Score
Mean 16-Week Change in Glasgow Depression Scale for people with a Learning Disability Carer Supplement (GDS-CS) Total Score
Mean 16-Week Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Mean 16-Week Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 16
Proportion of Participants Who Responded to Treatment at 16 Weeks According to Improvement Item of the Clinical Global Impression-Scale (Response Defined as CGI-I=1 or CGI-I=2)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Down Syndrome

Side Effects for

Fluoxetine
8%Weight Loss
8%Stomach Pains
4%Silliness/Feeling too happy
4%Dry Mouth
4%Sweating
4%Trouble Sleeping
4%Lit Paper on Fire
4%Nausea
4%Menstrual Cramps
4%Emotional
4%Nightmares
4%Insomnia
4%Decreased Appetite
4%Fatigue
4%Agitated/Restlessness
4%Headache
4%Suicidal Behavior
0%Drowsiness
0%Visit to ER: Aches
0%Itchiness
0%Feeling tense
0%Light hurts eyes
0%Ears ringing
0%Dizziness
0%Heart Pounding/Racing
0%Visit to ER: Family Conflict
0%Delay in Urination
0%Constipation
0%Weight Gain
0%Forgetfulness
0%Leg Spasms
0%Blurred/double Vision
0%Tingling
0%Numbness
0%Trouble Keeping Balance
0%Hair Loss
0%Room Spinning
This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT00245635) in the Fluoxetine ARM group. Side effects include: Weight Loss with 8%, Stomach Pains with 8%, Silliness/Feeling too happy with 4%, Dry Mouth with 4%, Sweating with 4%.

Trial Design

1 Treatment Group

Fluoxetine
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Fluoxetine · No Placebo Group · Phase 4

Fluoxetine
Drug
Experimental Group · 1 Intervention: Fluoxetine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
2005
Completed Phase 4
~2370

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 4, week 8, week 12, week 16
Closest Location: Lurie Center for Autism · Lexington, MA
Photo of Lexington 1Photo of Lexington 2Photo of Lexington 3
2020First Recorded Clinical Trial
1 TrialsResearching Down Syndrome
1 CompletedClinical Trials

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,660 Previous Clinical Trials
30,828,772 Total Patients Enrolled
3 Trials studying Down Syndrome
980 Patients Enrolled for Down Syndrome
Robyn P. Thom, MDPrincipal InvestigatorLurie Center for Autism

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a moderately severe depression as evidenced by a score of 20 or greater on the Montgomery-Asberg Depression Rating Scale (MADRS).
You have moderate symptoms of depression.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.