Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar

NCT00176202 | Completed Phase 3 Results DMC

• 1 other identifier: RIS-BIP-407
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

Brief Summary

The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. We show the mean and standard deviation at week 0 and 6.

  Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).

Secondary Outcomes (3)

• Child Depression Rating Scale- Revised (CDRS-R)

  Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).

• Child Mania Rating Scale (CMRS)

  Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).

• Clinical Global Improvement in Bipolar Disorder Overall (CGI-BP Overall)

  Six week study with assessment at baseline and end of the study (at the end of 6 weeks or earlier if they ended the study before 6 week end point).

Study Arms (2)

Risperidone

ACTIVE COMPARATOR

Risperidone is an antimanic medication and is a second generation antipsychotic

Drug: risperidone

Divalproex sodium

ACTIVE COMPARATOR

Divalproex sodium is an antiepileptic medication and is a mood stabilizer

Drug: Divalproex Sodium

Interventions

Divalproex Sodium DRUG

Divalproex sodium is a mood stabilizer

Also known as: antiepileptic, valproic acid

Divalproex sodium

risperidone DRUG

Risperidone is a second generation antipsychotic and antimanic drug

Also known as: antipsychotic, risperdal

Risperidone

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with Bipolar Disorder
• Must be able to swallow tablets

You may not qualify if:

• Children with general medical condition such as head injury, epilepsy, endocrine disorders
• Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
• If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (3)

Neuro Psychiatric Institute (NPI)

Chicago, Illinois, 60612, United States

Location

NPI, University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

NPI

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Pavuluri MN, Passarotti AM, Fitzgerald JM, Wegbreit E, Sweeney JA. Risperidone and divalproex differentially engage the fronto-striato-temporal circuitry in pediatric mania: a pharmacological functional magnetic resonance imaging study. J Am Acad Child Adolesc Psychiatry. 2012 Feb;51(2):157-170.e5. doi: 10.1016/j.jaac.2011.10.019. Epub 2011 Dec 23.

  PMID: 22265362 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid; Anticonvulsants; Risperidone; Antipsychotic Agents

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs

Results Point of Contact

• Title: Dr Mani Pavuluri
• Organization: University of Illinois at Chicago

mpavuluri@psych.uic.edu

3124130064

Study Officials

• Mani Pavuluri, MD

  University of Ilinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of BRAIN Center

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2003
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: November 5, 2015
• Results First Posted: November 5, 2015

Record last verified: 2015-11

Locations

US (3)