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Atypical Antipsychotic
SSRI + Antipsychotic for Compulsive Behavior in Intellectual Disability
Phase 3
Waitlist Available
Led By Mark Lewis, PhD
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ambulatory
Free of sensory deficits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying whether two medications, an SSRI and an atypical antipsychotic, are effective in treating repetitive behavior disorders in people with mental retardation.
Who is the study for?
This trial is for individuals with severe mental retardation who exhibit repetitive behaviors, are medically stable, can walk, and live in specific communities in NC or FL. They must not have sensory deficits or recent seizures. Those with poor health, cardiac/hepatic/renal issues, tardive dyskinesia, akathisia, recent neuroleptic use, ergot sensitivity or hypertension cannot join.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of an SSRI (commonly used for depression) and an atypical antipsychotic (used for various psychiatric disorders) in treating repetitive behavior disorders among people with severe mental retardation.See study design
What are the potential side effects?
SSRIs may cause nausea, headache, sleep disturbances and sexual dysfunction. Atypical antipsychotics can lead to weight gain, diabetes risk increase, drowsiness and sometimes involuntary movements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk on my own without help.
Select...
I do not have any loss of feeling.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,964 Previous Clinical Trials
2,674,730 Total Patients Enrolled
Mark Lewis, PhDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had a seizure in the last 4 months, even if I'm on medication.I have been diagnosed with tardive dyskinesia.I have heart, liver, or kidney problems.I can walk on my own without help.I have high blood pressure.You have a condition that affects your ability to learn and understand things.You often repeat the same behaviors and may hurt yourself or feel like you have to do certain things over and over.You have had a bad reaction to ergot alkaloids in the past.I experience a strong urge to move or restlessness.You are in overall poor health.I have not taken any antipsychotic drugs in the last 6 months.I do not have any loss of feeling.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are people who are below the age of 30 able to participate in this research?
"This study allows people who are aged 18-55 to participate."
Answered by AI
Are investigators still enrolling patients in this experiment?
"The listing on clinicaltrials.gov indicates that this study is not recruiting patients at the moment. This particular trial was originally posted on September 1st, 1992 and last updated on June 22nd, 2007. There are other opportunities to participate in medical research, as 88 other trials are currently looking for candidates."
Answered by AI
Could you please list the side effects of this medication?
"This treatment received a safety score of 3 from our analysts at Power. This is due to the fact that this is a Phase 3 trial, so there is already some evidence of efficacy as well as several rounds of data supporting safety."
Answered by AI
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