NCT00221429

Brief Summary

This study compared the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_3

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

March 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

5.4 years

First QC Date

September 14, 2005

Last Update Submit

February 5, 2024

Conditions

Bipolar Disorder

Keywords

childadolescent

Outcome Measures

Primary Outcomes (1)

  • Young Mania Rating Scale (YMRS) & Clinical Global Impressions I (CGI-I)

    8 weeks

Secondary Outcomes (1)

  • CDRS & MRS

    8 weeks

Interventions

LithiumDRUG

lithium

Also known as: Lithobid
sodium divalproexDRUG

Depakote

Also known as: Depakote
PlaceboOTHER

Placebo

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria
  • Score of \> 14 on the Y-MRS
  • Normal intelligence
  • Ability and willingness to provide assent and informed, written consent from at least one parent or legal guardian
  • No current general medical illnesses requiring medication

You may not qualify if:

  • \. A current or lifetime DSM-IV diagnosis of schizophrenia, autistic disorder, schizoaffective disorder, pervasive developmental disorder, or obsessive compulsive disorder 2. IQ \< 70 3. Patients with serious suicide risk 4. Concurrent cognitive-behavior therapy that is specifically focused on the child or adolescent's bipolar symptoms within 6 weeks of enrolling in this trial.
  • \. Any use of psychotropic agents within the preceding 2 weeks, including neuroleptics, monoamine oxidase inhibitors, stimulants, antidepressants, or depot neuroleptics or fluoxetine in the past month 6. Current or history in past 3 months of a DSM-IV diagnosis of Substance Abuse/Dependence or use of illicit drugs or alcohol in the past 3 weeks. Patients who have a positive drug screen at intake, who would otherwise be eligible for the study, will be given the opportunity to repeat the drug screen 3 weeks later. They will be excluded if the second drug screen is positive.
  • \. Pregnancy or sexually active females not using a reliable form of contraception 8. Previous adequate trial of either LI or DVP defined as; 3 weeks of DVP at serum levels between 75-125 OR dosage of at least 20 mg/kg; Lithium for at least 4 weeks at serum levels of .8 - 1.2 or dosage of at least 30 mg/kg.
  • \. Allergies to LI, DVP or chlorpromazine. 10. Bipolar subjects who are currently stable on mood stabilizers or atypical neuroleptics.
  • \. Bipolar subjects with Bipolar I disorder and ADHD who are stable on stimulants with or without concurrent mood stabilizers.
  • \. Inpatient hospitalization within 6 months prior to screening. Partial hospitalization is acceptable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center/Medical Sciences Building

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

LithiumLithium CarbonateValproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsCarbonatesAlkaliesCarbonic AcidCarbon Compounds, InorganicLithium CompoundsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Robert A. Kowatch, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

March 1, 2001

Primary Completion

August 1, 2006

Study Completion

February 1, 2015

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

US(1)