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Sponsored by: |
University of Illinois |
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Information provided by: | University of Illinois |
ClinicalTrials.gov Identifier: | NCT00176202 |
There are two purposes for this project. Study 1 is to determine whether risperidone is better than divalproex sodium in treating/stabilizing pediatric bipolar disorder. Study 2 is to look at the dysfunction in brain activity before treatment, and to look for any alteration after treatment with either risperidone or divalproex sodium. One initial part of Study 2 is looking at 10 healthy control adults to learn what areas of the brain are activated when the subject is exposed to faces showing different emotions, and when the subject is asked to determine emotionality, age, and recall of faces.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: Divalproex Sodium Drug: risperidone |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Controlled Trial of Risperidone and Divalproex Sodium With MRI Assessment of Affected Circuitry in Pre and Post Treatment in Pediatric Bipolar |
Estimated Enrollment: | 210 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | January 2008 |
Pediatric Bipolar Disorder (PBD) severely impairs a child’s emotional development, and is associated with alarming rates of suicide, school failure, aggression, risk taking behaviors and substance abuse (Geller et al, 1998; 2001; Carlson et al, 1998). At present, very little is known about the pathophysiology or optimal treatment of PBD. The long range goals of this proposal are threefold: to investigate a range of pharmacotherapeutic agents that are safe and efficacious for PBD, to use fMRI techniques to examine abnormalities in brain function in this disorder, as well as any change in brain function after treatment.
In contrast to the adult literature, we are aware of only two prospective studies assessing the efficacy of standard mood stabilizers in a pediatric sample. In one, lithium was found to be moderately effective in PBD with comorbid substance abuse (Geller et al, 1998). In the other, divalproex sodium, lithium and carbamazepine produced a maximum of 50% symptom reduction (Kowatch et al, 2000). Subsequently, Kafantaris et al (2001) observed a potentiation of lithium's antimanic effect when combined with risperidone. Further, a prospective, open trial of olanzapine for PBD reported a 70% symptom reduction (Frazier et al, 2001) with a retention rate of 96% compared to only 7% with classic mood stabilizers (Kowatch et al, 2000).
Thus, parallelling adult studies (Sachs et al, 2000), novel antipsychotics are a promising treatment in this population. Further, up to 60% of acute PBD episodes present with psychotic features (Geller et al, in press). Finally, the time to full effect with mood stabilizers is often 4 weeks in children (Kowatch et al, 2000; Geller et al, 1998; Kafantaris et al, 2001), whereas antipsychotics usually have a more rapid response onset (Pavuluri et al, in press). Given the potential efficacy of novel antipsychotics for PBD, the aim is to conduct a randomized trial comparing a novel antipsychotic to a standard mood stabilizer:
Ages Eligible for Study: | 10 Years to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
We expect only a small number of children to be excluded from the study due to exclusionary criteria. Selection of the subjects is not based on sex, race, or ethnic group.
For the fMRI study:
Healthy Individuals/Controls:
Contact: Melissa S Moss, BA | 312-355-1911 | mmoss@psych.uic.edu |
Contact: Erin M Harral, BA | 312-413-1710 | eharral@psych.uic.edu |
United States, Illinois | |
NPI | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Mani Pavuluri, MD 312-413-1722 mpavuluri@psych.uic.edu | |
Principal Investigator: Mani Pavuluri, MD |
Principal Investigator: | Mani Pavuluri, MD | University of Ilinois at Chicago |
Study ID Numbers: | RIS-BIP-407 |
Study First Received: | September 9, 2005 |
Last Updated: | April 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00176202 |
Health Authority: | United States: Institutional Review Board |
Affective Disorders, Psychotic Dopamine Mental Disorders Bipolar Disorder Risperidone |
Mood Disorders Psychotic Disorders Valproic Acid Serotonin |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Enzyme Inhibitors Antipsychotic Agents |
Antimanic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses GABA Agents Dopamine Agents Central Nervous System Agents Anticonvulsants |