- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825552
Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation
Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation. An Open Trial With Risperidone.
Study Overview
Detailed Description
Severe Mood Dysregulation(SMD) is a new construct in children and adolescents characterized by persistent and non episodic irritability, hyperarousal and emotional reactivity.
This is an open label trial using Risperidone in children and adolescents( 7-17 years old) diagnosed with SMD.
We hypothesized that Risperidone would improve externalizing symptoms as well as depressive and/or maniac symptomatology. We also consider the effect of the pharmacological intervention in the co-morbid disorders especially ADHD.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90350-903
- Hospital de Clínicas de Porto Alegre
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90000-010
- Hospital de Clínicas de Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnose of Severe Mood Dysregulation
- 7-17 years
- IQ > 70
Exclusion Criteria:
- Bipolar disorder
- IQ<70
- Psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
We use as the primary outcome the subscale of irritability of the Aberrant Checklist Behavior which measures the intensity of irritability, temper tantruns and hyperarousal symptoms
Time Frame: 11/2010
|
11/2010
|
Collaborators and Investigators
Investigators
- Study Chair: Rohde A Luis, Phd, Federal University of Rio Grande do Sul
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19091979
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Severe Mood Dysregulation
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)CompletedSevere Mood DysregulationUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)CompletedSevere Mood DysregulationUnited States
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); ShireCompletedSevere Mood DysregulationUnited States
-
Weill Medical College of Cornell UniversityCompleted
-
Tri-Service General HospitalMinistry of Science and Technology, TaiwanCompletedDisruptive Mood Dysregulation Disorder
-
VA Palo Alto Health Care SystemSeoul SemiconductorCompletedSleep | Mood | Circadian DysregulationUnited States
-
Centre Hospitalier Universitaire, AmiensRecruitingDisruptive Mood Dysregulation Disorder | Prognosis Factors | Suicidal Behaviors | ActigraphyFrance
-
Neuromotion LabsNational Institute of Mental Health (NIMH); Magellan HealthcareRecruiting
-
Karolinska InstitutetTerminatedEmotional DysregulationSweden
-
Centre Hospitalier Universitaire de BesanconCompleted
Clinical Trials on Risperidone
-
Rovi Pharmaceuticals LaboratoriesCompletedAcute SchizophreniaUnited States, Ukraine
-
Northwestern UniversityOrtho-McNeil Janssen Scientific Affairs, LLCCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Rovi Pharmaceuticals LaboratoriesCompletedSchizophrenia | Schizoaffective DisorderSpain, South Africa, Russian Federation, Croatia
-
Zogenix, Inc.CompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Zogenix, Inc.Completed
-
Janssen-Cilag S.p.A.CompletedSchizophrenia | Schizoaffective Disorder
-
Rovi Pharmaceuticals LaboratoriesRecruiting
-
Xijing HospitalUnknown
-
Hoffmann-La RocheCompleted
-
Janssen Korea, Ltd., KoreaCompleted