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Selective Serotonin Reuptake Inhibitor
Fluoxetine for Depression in Down Syndrome
Phase 4
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 8, week 12, week 16
Awards & highlights
Study Summary
This trial will test whether fluoxetine is an effective, safe, and tolerable treatment for depression in adults with Down syndrome.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
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 moreSide effects data
From 2012 Phase 4 trial • 43 Patients • NCT002456358%
Stomach Pains
8%
Weight Loss
4%
Nausea
4%
Trouble Sleeping
4%
Insomnia
4%
Nightmares
4%
Menstrual Cramps
4%
Silliness/Feeling too happy
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
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
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,931 Previous Clinical Trials
13,198,420 Total Patients Enrolled
3 Trials studying Down Syndrome
980 Patients Enrolled for Down Syndrome
Robyn P. Thom, MDPrincipal InvestigatorLurie Center for Autism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, bipolar disorder, psychosis, or substance use disorder.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.I have stopped taking certain mental health medications for a specific time before the trial.I have tried fluoxetine before.My current mental health medications are not working well for me.I am taking medication that could dangerously interact with fluoxetine.I have been diagnosed with moderately severe depression.I have been diagnosed with major depressive disorder.My depression is moderate or severe.You have a very serious intellectual disability based on a doctor's evaluation and tests of thinking skills.I am between 18 and 45 years old.I have been diagnosed with dementia or take medication for it.My Down syndrome diagnosis was confirmed through genetic testing or by an experienced clinician.
Research Study Groups:
This trial has the following groups:- Group 1: Fluoxetine
Awards:
This trial has 5 awards, including:- 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.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a risk for any adverse effects when taking Fluoxetine?
"There is ample evidence of Fluoxetine's safety from Phase 4 trials, earning it a score of 3."
Answered by AI
What eligibility criteria are necessary to partake in this medical experiment?
"For entry into this clinical trial, 25 people with Down syndrome between 18 and 45 years old are being accepted. In order to meet the criteria for enrolment in the study, participants need: a genetic test result or diagnosis from an experienced clinician that confirms their DS status; DSM-5 criteria confirming major depressive disorder as diagnosed by SCID-5; witnessable moderate depression scores (20+) on the MADRS scale at both Screening and Baseline; plus CGIS > 4 (moderate) for symptoms of depression at those same points."
Answered by AI
Are there currently opportunities to join this experiment?
"Clinicaltrials.gov data confirms that this medical trial is not presently recruiting, despite having been posted on August 1st 2022 and last updated July 13th 2022. Fortunately, there are still 2,671 other clinical trials actively seeking participants at this juncture."
Answered by AI
Is participation in the trial limited to individuals who have reached adulthood?
"The eligibility criteria for this trial stipulates that participants must be of legal age and younger than 45 years old."
Answered by AI
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