NCT00000385

Brief Summary

This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 1997

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

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

6.3 years

First QC Date

November 2, 1999

Last Update Submit

November 25, 2013

Conditions

Conduct DisorderAggression

Keywords

Aggressive conduct disorderAdolescenceChildConduct DisorderFemaleLithiumMalePlacebosConduct Disorder -- *drug therapyLithium -- *therapeutic use

Outcome Measures

Primary Outcomes (2)

  • Overt Aggression Scale-Modified

    Weekly in short term phase, Monthly in long-term phase

  • Clinical Global Impressions-Improvement Item

    Weekly in short term phase, Monthly in long-term phase

Secondary Outcomes (4)

  • Children's Psychiatric Rating Scale-Selected Items

    Weekly in short term phase, Monthly in long-term phase

  • IOWA

    Weekly in short term phase, Monthly in long-term phase

  • DOTES

    Weekly in short term phase, Monthly in long-term phase

  • TESS

    Weekly in short term phase, Monthly in long-term phase

Study Arms (2)

1

EXPERIMENTAL

Lithium 600 mg to 2700 mg per day

Drug: Lithium

2

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

LithiumDRUG

Lithium 600 mg to 2700 mg per day

1
PlaceboDRUG

Matching placebo

2

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Males and females
  • Ages between 9 and 17 years.
  • Conduct disorder according to DSM-IV (As rated on the DICA-IV).
  • The aggression criterion at screening

You may not qualify if:

  • Mental Retardation.
  • Pervasive Developmental Disorder(s).
  • Major Depressive Disorder or Dysthymic Disorder.
  • Bipolar Disorder.
  • Psychotic Disorder (including Schizophreniform Disorder and Schizophrenia).
  • Major medical problem such as cardiac, renal, and thyroid diseases, or seizure disorder.
  • History of psychoactive medication in the previous 2 weeks.
  • Current Pregnancy in females.
  • History of Substance Dependence in the past month.
  • Prior to the proposed study, a history of lithium treatment with serum lithium levels of 0.4 mEq/L or higher for a cumulative period of greater than 10 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University College of Medicine at Friends Hospital

Philadelphia, Pennsylvania, 19124, United States

Location

MeSH Terms

Conditions

Conduct DisorderAggression

Interventions

Lithium

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Richard P. Malone, MD

    Drexel University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

September 1, 1997

Primary Completion

December 1, 2003

Study Completion

June 1, 2005

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

US(1)