NCT00036582

Brief Summary

The purpose of this study is to determine the safety and effectiveness of clozapine in children and adolescents with treatment resistant bipolar disorder. This study will also explore how the brain functions in early-onset bipolar disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2002

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2004

First QC Date

May 10, 2002

Last Update Submit

March 3, 2008

Conditions

Bipolar Disorder

Keywords

PsychophysiologyStructural MRIGeneticsBipolar DisorderChildren and AdolescentsClozapinePlaceboTreatment-RefractoryBipolarHealthy VolunteerHVBPDNormal Control

Interventions

ClozapineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 8-17
  • Currently meets criteria for bipolar disorder, manic or mixed, as determined by the K-SADS diagnostic interview.
  • Treatment-resistant, defined as a history of unsuccessful trials of lithium (documented level of greater than 0.8 mEq/L), valproic acid (documented level of greater than 50 ug/ml), carbamazepine (documented level greater than or equal to 6 ug/ml), a neuroleptic as well as a combination of two of these agents. Each trial must have been at least 6 weeks long. A trial will be considered unsuccessful if the medication was discontinued because of intolerable side-effects.
  • The child should be in treatment with a community psychiatrist to whom they will return upon completion of the study.
  • Current CGAS score less than 50

You may not qualify if:

  • Full scale IQ less than 80
  • Meets criteria for substance use disorder in the three months prior to randomization
  • Currently pregnant, lactating, or sexually active without using a barrier method of contraception
  • Previous treatment with clozapine
  • History of seizures
  • History of leukopenia or agranulocytosis
  • Presence of an unstable medical illness
  • Control subjects will be age- and sex- matched to the BPD subjects. They will have normal physical and neurological examinations, and an identified primary care physician. Both control subjects and their first-degree relatives must be free of current or past psychopathology.
  • I.Q less than 80; ongoing medical illness; neurologic disorder (including seizures); pregnancy; meeting past or present criteria for any diagnosis on the K-SADS-PL; meeting criterion A of post-traumatic stress disorder (exposure to a traumatic event).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Wozniak J, Biederman J, Kiely K, Ablon JS, Faraone SV, Mundy E, Mennin D. Mania-like symptoms suggestive of childhood-onset bipolar disorder in clinically referred children. J Am Acad Child Adolesc Psychiatry. 1995 Jul;34(7):867-76. doi: 10.1097/00004583-199507000-00010.

    PMID: 7649957BACKGROUND

  • Geller B, Sun K, Zimerman B, Luby J, Frazier J, Williams M. Complex and rapid-cycling in bipolar children and adolescents: a preliminary study. J Affect Disord. 1995 Aug 18;34(4):259-68. doi: 10.1016/0165-0327(95)00023-g.

    PMID: 8550951BACKGROUND

  • Faedda GL, Baldessarini RJ, Suppes T, Tondo L, Becker I, Lipschitz DS. Pediatric-onset bipolar disorder: a neglected clinical and public health problem. Harv Rev Psychiatry. 1995 Nov-Dec;3(4):171-95. doi: 10.3109/10673229509017185.

    PMID: 9384947BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

May 10, 2002

First Posted

May 13, 2002

Study Start

May 1, 2002

Study Completion

February 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-02

Locations

US(1)