Expired Study
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Glen Oaks, New York 11004


Purpose:

This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.


Study summary:

In children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted. Participants in this study are treated with lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. The first group will continue to receive active mood stabilizer and atypical antipsychotic medication. The second group will receive active mood stabilizer and placebo. Participants are assessed weekly and followed for up to 18 months.


Criteria:

Inclusion criteria: - Have a diagnosis of Bipolar I Disorder; - Have had aggressive and/or psychotic features (delusions, hallucinations and/or thought disorder) during the most recent manic episode; - Is willing to be treated or is already being treated with the combination of mood stabilizer(s) (lithium or Depakote) and an atypical antipsychotic medication (Abilify, Geodon, Risperdal, Seroquel, or Zyprexa); - Live in the NY Metropolitan area; - Able to attend weekly to biweekly office visits Exclusion Criteria: - Medical contraindication to treatment with lithium and divalproex - Seizure disorder - Pregnancy - Unwillingness to use acceptable methods of birth control if sexually active - IQ less than 70 - Substance-induced mood disorder or mood disorder due to a general medical condition - Prior experience with re-emergence of psychotic features or severe aggression within 6 months of antipsychotic medication discontinuation under circumstances similar to those in the study - Potentially lethal suicide attempts or infliction of serious injury upon someone during most severe bipolar episode - High risk for running away or truancy


Study is Available At:


Original ID:

R01 MH60845


NCT ID:

NCT00048802


Secondary ID:

R01MH060845


Study Acronym:


Brief Title:

Treatment and Outcome of Early Onset Bipolar Disorder


Official Title:

Treatment and Outcome of Early Onset Bipolar Disorder


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

10 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

North Shore Long Island Jewish Health System


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:


Study Dates

Start Date:August 2002
Completion Date:August 2006
Completion Type:Actual
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:January 2014
Last Changed Date:January 21, 2014
First Received Date:November 8, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Lithium
Intervention Type:Drug
Name:Olanzapine
Intervention Type:Drug
Name:Divalproex
Intervention Type:Drug
Name:Risperidone
Intervention Type:Drug
Name:Quetiapine
Intervention Type:Drug
Name:Ziprasidone
Intervention Type:Drug
Name:Aripriprazole

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:North Shore Long Island Jewish Health System
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Adjunctive antipsychotic treatment of adolescents with bipolar psychosis. J Am Acad Child Adolesc Psychiatry. 2001 Dec;40(12):1448-56.
PMID:11765291
Reference Type:Reference
Citation:Kafantaris V. Treatment of bipolar disorder in children and adolescents. J Am Acad Child Adolesc Psychiatry. 1995 Jun;34(6):732-41. Review.
PMID:7608046
Reference Type:Reference
Citation:Kafantaris V, Coletti DJ, Dicker R, Padula G, Kane JM. Lithium treatment of acute mania in adolescents: a large open trial. J Am Acad Child Adolesc Psychiatry. 2003 Sep;42(9):1038-45.
PMID:12960703

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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