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Selective Serotonin Reuptake Inhibitor

Fluoxetine for Depression in Down Syndrome

Phase 4
Waitlist Available
Led By Robyn P. Thom, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderately severe depression as evidenced by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or greater at Screen and Baseline
Diagnosis of major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, confirmed through the Structured Clinical Interview for DSM-5 (SCID-5)
Must not have
Use of medications that pose a clinically significant risk of a drug-drug interaction with fluoxetine
Presence of any past or present conditions that would make treatment with fluoxetine unsafe. This includes allergy to fluoxetine, liver or kidney disease, unstable heart disease, and/or pregnancy (or being sexually active without using acceptable methods to prevent pregnancy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, week 12, week 16
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing whether fluoxetine, a common depression medication, is safe and effective for adults with Down syndrome. The study will last several months, with doses adjusted initially and then kept stable towards the end. Researchers will monitor side effects and measure depression levels throughout the study. Fluoxetine, commonly known as Prozac, has been widely studied and used for treating major depression since its introduction.

Who is the study for?
Adults aged 18-45 with Down syndrome and moderate to severe depression, confirmed by specific clinical assessments, can join this trial. They must not have any conditions that make fluoxetine unsafe like allergies to it, liver/kidney disease, unstable heart disease or be pregnant without contraception. Participants should not be on certain antidepressants or psychotropic drugs before the trial.
What is being tested?
The study is testing if fluoxetine is an effective and safe treatment for adults with Down syndrome who are experiencing depression. It's a preliminary assessment focusing on the drug's impact on depressive symptoms in this particular group.
What are the potential side effects?
Fluoxetine may cause side effects such as headaches, nausea, sleepiness or insomnia, nervousness, dry mouth and sexual problems. In some cases it might also lead to more serious issues like allergic reactions or changes in mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with moderately severe depression.
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I have been diagnosed with major depressive disorder.
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My depression is moderate or severe.
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I am between 18 and 45 years old.
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My Down syndrome diagnosis was confirmed through genetic testing or by an experienced clinician.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication that could dangerously interact with fluoxetine.
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I do not have conditions that make fluoxetine unsafe for me, including allergies, liver or kidney disease, unstable heart disease, and I am not pregnant nor at risk of becoming pregnant without contraception.
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I have tried fluoxetine before.
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I have been diagnosed with dementia or take medication for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8, week 12, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8, week 12, week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Secondary study objectives
Mean 16-Week Change in Glasgow Depression Scale for people with a Learning Disability (GDS-LD) Total Score
Mental Depression
Mean 16-Week Change in Hamilton Depression Rating Scale (HAM-D) Total Score
+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

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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: FluoxetineExperimental Treatment1 Intervention
Subjects will receive fluoxetine 5 mg each morning at the start of the trial. The dose will be increased by 5 mg every 2 weeks depending on effectiveness and tolerability. The optimal dose will be reached by week 12 of treatment. The minimum starting dose will be 5 mg and the maximum total daily dose will be 30 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Selective Serotonin Reuptake Inhibitors (SSRIs), such as Fluoxetine, function by increasing serotonin levels in the brain through the inhibition of its reuptake into neurons. This mechanism is particularly important for Down Syndrome patients as serotonin plays a crucial role in mood regulation, cognitive function, and overall brain health. By enhancing serotonin levels, SSRIs can potentially improve mood, reduce anxiety, and enhance cognitive abilities, addressing common challenges faced by individuals with Down Syndrome.
Antidepressants induce toxicity in human placental BeWo cells.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,276 Total Patients Enrolled
3 Trials studying Down Syndrome
976 Patients Enrolled for Down Syndrome
Robyn P. Thom, MDPrincipal InvestigatorLurie Center for Autism

Media Library

Fluoxetine (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05458479 — Phase 4
Down Syndrome Research Study Groups: Fluoxetine
Down Syndrome Clinical Trial 2023: Fluoxetine Highlights & Side Effects. Trial Name: NCT05458479 — Phase 4
Fluoxetine (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05458479 — Phase 4
~2 spots leftby Nov 2025