What side effects are associated with this type of intervention?

Common treatments for Down Syndrome, particularly those similar to Fluoxetine (an SSRI), often include managing depression and anxiety. Known side effects of SSRIs include nausea, headache, sleep disturbances, dry mouth, dizziness, and sexual dysfunction. There is also an increased risk of suicidal thoughts, especially in young adults and adolescents. Monitoring and discussing any side effects with a healthcare provider is crucial.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Down Syndrome itself. However, treatments for associated conditions such as depression in individuals with Down Syndrome may include SSRIs like Fluoxetine. SSRIs are commonly used to increase serotonin levels in the brain and manage symptoms of depression. The study mentioned aims to assess the efficacy, safety, and tolerability of Fluoxetine for treating depression in adults with Down Syndrome, which aligns with the broader use of SSRIs in managing depressive symptoms.

What other types of research exist?

Promising alternatives to Fluoxetine for Down Syndrome patients include Sertraline and Escitalopram, both of which are SSRIs with a favorable safety profile. Additionally, Venlafaxine, an SNRI, may be considered due to its efficacy in treating depression. These alternatives should be discussed with a healthcare provider to tailor treatment to the individual patient's needs.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, week 8, week 12, week 16

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

Weight Loss

Stomach Pains

Silliness/Feeling too happy

Trouble Sleeping

Nausea

Menstrual Cramps

Insomnia

Nightmares

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

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

0 / 9Eligibility criteria met

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.