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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
Must not have
Tardive dyskinesia
Cardiac, hepatic, or renal abnormalities
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 below
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I can walk on my own without help.
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I do not have any loss of feeling.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with tardive dyskinesia.
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I have heart, liver, or kidney problems.
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I have high blood pressure.
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I experience a strong urge to move or restlessness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,988 Previous Clinical Trials
2,683,523 Total Patients Enrolled
Mark Lewis, PhDPrincipal InvestigatorUniversity of Florida

Media Library

Atypical Antipsychotic (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT00491478 — Phase 3
Compulsive Behavior Research Study Groups:
Compulsive Behavior Clinical Trial 2023: Atypical Antipsychotic Highlights & Side Effects. Trial Name: NCT00491478 — Phase 3
Atypical Antipsychotic (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00491478 — Phase 3
~11 spots leftby Jun 2025
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