Mental RetardationPhase 3NCT00491478
Repetitive Behavior Disorders in People With Severe Mental Retardation
A Phase 3 study testing sertraline in people with Mental Retardation and Stereotyped Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
Repetitive behavior disorders are prevalent among people with severe mental retardation. These disorders can interfere significantly with an individual's daily functions. This trial is part of a long-term project that has studied the biologic basis of and possible treatments for repetitive behavior disorders. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mental Retardation, Stereotyped Behavior, Self-Injurious Behavior
- What is being tested?
- sertraline
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Sep 1992to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mental retardation
- Medically stable resident of either Western Carolina Center, Morganton, NC or Tacachale Community, Gainesville, FL
- Free of sensory deficits
- Ambulatory
- High rate of stereotyped behavior that may co-occur with self-injurious or compulsive behaviors
Who cannot join
- Poor general health
- Cardiac, hepatic, or renal abnormalities
- Seizure within 4 months prior to study entry (patients on seizure medication who have not had a seizure within 4 months prior to study entry may participate)
- Tardive dyskinesia
- Akathisia
- Neuroleptic use within 6 months of study entry
- History of sensitivity to ergot alkaloids
- Hypertension
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Department of Psychiatry
Gainesville, Florida, 32610-0256
- Recruiting
Western Carolina Center
Morganton, North Carolina, 28655
James W. Bodfish, PhD, 828-483-6518, Jim.Bodfish@westerncarolinacenter.org
About this study
Official title: Stereotypies and Mental Retardation: Neurobiological Basis
Repetitive behavior disorders are prevalent among people with severe mental retardation. These disorders can interfere significantly with an individual's daily functions. This trial is part of a long-term project that has studied the biologic basis of and possible treatments for repetitive behavior disorders. The trial will evaluate the effectiveness of two medications, a selective serotonin reuptake inhibitor (SSRI) and an atypical antipsychotic, in treating repetitive behavior disorders in people with mental retardation.
Read the detailed description
Abnormal repetitive behaviors (odd or inappropriate movements, self-injury, and compulsions) are among the aberrant behaviors exhibited by individuals with mental retardation. However, little is known about their pathobiology and treatments are largely unconfirmed by controlled trials. For example, few controlled studies have examined the efficacy of pharmacological treatment of abnormal repetitive behavior in individuals with mental retardation.
This trial is part of a larger project designed to elucidate the neurobiological bases of repetitive behavior disorders and to develop rational, safe, and effective pharmacological treatments. Thus far, the project has established a pathophysiological basis for stereotyped behavior disorder, demonstrated the role of central dopamine deficiency in stereotyped behavior disorder, and provided evidence of the efficacy of both 5-HT uptake inhibitors and atypical antipsychotics in treating stereotyped behaviors.
There is currently little information to guide the clinician in deciding which drug class may be more effective for which abnormal repetitive behaviors and for which individuals. Moreover, little work has attempted to identify variables that may predict differential treatment response. This trial will assess the relative efficacy of an SSRI and an atypical antipsychotic across multiple categories of abnormal repetitive behaviors.
- Being tested
- sertraline
- Keywords
- Repetitive behavior disorder, Stereotypy, Sertraline
- Medical subject headings
- Intellectual Disability, Stereotyped Behavior, Self-Injurious Behavior, Compulsive Behavior, Stereotypic Movement Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startSep 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Mark Lewis, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491478
- Sponsor's protocol ID
- R01HD030615
- Status last verified
- May 2003
- First submitted
- 22 Jun 2007
- Last updated
- 26 Jun 2007
- Results posted
- No
Publications
Bodfish JW, Crawford TW, Powell SB, Parker DE, Golden RN, Lewis MH. Compulsions in adults with mental retardation: prevalence, phenomenology, and comorbidity with stereotypy and self-injury. Am J Ment Retard. 1995 Sep;100(2):183-92.
PubMed 8527113Lewis MH, Bodfish JW, Powell SB, Wiest K, Darling M, Golden RN. Plasma HVA in adults with mental retardation and stereotyped behavior: biochemical evidence for a dopamine deficiency model. Am J Ment Retard. 1996 Jan;100(4):413-8. No abstract available.
PubMed 8718995Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43. doi: 10.1023/a:1005596502855.
PubMed 11055459Bodfish JW, Parker DE, Lewis MH, Sprague RL, Newell KM. Stereotypy and motor control: differences in the postural stability dynamics of persons with stereotyped and dyskinetic movement disorders. Am J Ment Retard. 2001 Mar;106(2):123-34. doi: 10.1352/0895-8017(2001)1062.0.CO;2.
PubMed 11321603
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotypies and Mental Retardation: Neurobiological Basis
- ClinicalTrials.gov ID
- NCT00491478
- Acronym / sponsor ID
- R01HD030615
- Keywords
- Repetitive behavior disorder, Stereotypy, Sertraline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Sep 1992
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repetitive behavior disorders are prevalent among people with severe mental retardation. These disorders can interfere significantly with an individual's daily functions. This trial is part of a long-term project that has studied the biologic basis of and possible treatments for repetitive behavior disorders. The trial will evaluate the effectiveness of two medications, a selective serotonin reuptake inhibitor (SSRI) and an atypical antipsychotic, in treating repetitive behavior disorders in people with mental retardation.
Detailed description
Abnormal repetitive behaviors (odd or inappropriate movements, self-injury, and compulsions) are among the aberrant behaviors exhibited by individuals with mental retardation. However, little is known about their pathobiology and treatments are largely unconfirmed by controlled trials. For example, few controlled studies have examined the efficacy of pharmacological treatment of abnormal repetitive behavior in individuals with mental retardation.
This trial is part of a larger project designed to elucidate the neurobiological bases of repetitive behavior disorders and to develop rational, safe, and effective pharmacological treatments. Thus far, the project has established a pathophysiological basis for stereotyped behavior disorder, demonstrated the role of central dopamine deficiency in stereotyped behavior disorder, and provided evidence of the efficacy of both 5-HT uptake inhibitors and atypical antipsychotics in treating stereotyped behaviors.
There is currently little information to guide the clinician in deciding which drug class may be more effective for which abnormal repetitive behaviors and for which individuals. Moreover, little work has attempted to identify variables that may predict differential treatment response. This trial will assess the relative efficacy of an SSRI and an atypical antipsychotic across multiple categories of abnormal repetitive behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Mental retardation
- Medically stable resident of either Western Carolina Center, Morganton, NC or Tacachale Community, Gainesville, FL
- Free of sensory deficits
- Ambulatory
- High rate of stereotyped behavior that may co-occur with self-injurious or compulsive behaviors
Key exclusion criteria (8 listed)
- Poor general health
- Cardiac, hepatic, or renal abnormalities
- Seizure within 4 months prior to study entry (patients on seizure medication who have not had a seizure within 4 months prior to study entry may participate)
- Tardive dyskinesia
- Akathisia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertraline | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2007.
- Background: PubMed 8527113Bodfish JW, Crawford TW, Powell SB, Parker DE, Golden RN, Lewis MH. Compulsions in adults with mental retardation: prevalence, phenomenology, and comorbidity with stereotypy and self-injury. Am J Ment Retard. 1995 Sep;100(2):183-92.
- Background: PubMed 8718995Lewis MH, Bodfish JW, Powell SB, Wiest K, Darling M, Golden RN. Plasma HVA in adults with mental retardation and stereotyped behavior: biochemical evidence for a dopamine deficiency model. Am J Ment Retard. 1996 Jan;100(4):413-8. No abstract available.
- Background: PubMed 11055459Bodfish JW, Symons FJ, Parker DE, Lewis MH. Varieties of repetitive behavior in autism: comparisons to mental retardation. J Autism Dev Disord. 2000 Jun;30(3):237-43. doi: 10.1023/a:1005596502855.
- Background: PubMed 11321603Bodfish JW, Parker DE, Lewis MH, Sprague RL, Newell KM. Stereotypy and motor control: differences in the postural stability dynamics of persons with stereotyped and dyskinetic movement disorders. Am J Ment Retard. 2001 Mar;106(2):123-34. doi: 10.1352/0895-8017(2001)1062.0.CO;2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Lewis, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sertraline in people with Mental Retardation and Stereotyped Behavior, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Lewis, PhD (352-392-3471, mlewis@psych.med.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00491478, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2007.