Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000385
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-11-02
Brief Title:
Long-Term Lithium Treatment for Aggressive Conduct Disorder
Sponsor:
Drexel University
Organization:
Drexel University
Study Overview
Official Title:
Long-Term Lithium for Aggressive Conduct Disorder
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder severe aggression
Detailed Description:
Psychotherapeutic agents are often administered without sufficient testing to children and adolescents often on a long-term basis to reduce aggression Many pressures including managed care will increase the utilization of pharmacotherapy in the outpatient setting to treat serious problems Lithium is the most promising agent for the treatment of aggression in children and adolescents However it has not been shown that lithium is an effective treatment for these patients in the outpatient non-hospital setting or on a long-term basis The purpose of this study is to examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder severe aggression
The proposed study is a two-phased clinical trial of lithium for the treatment of aggression in conduct disorder Both phases are double-blind and placebo-controlled with randomization and employ a parallel groups design Phase 1 contains a short-term 8-week controlled trial with twice as many subjects randomized to lithium as placebo increasing the pool of potential lithium responders to continue to Phase 2 In Phase 2 lithium responders from Phase 1 enter a 6-month long-term controlled trial Every attempt is made to define responders to lithium
The proposed study is a two-phased clinical trial of lithium for the treatment of aggression in conduct disorder Both phases are double-blind and placebo-controlled with randomization and employ a parallel groups design Phase 1 contains a short-term 8-week controlled trial with twice as many subjects randomized to lithium as placebo increasing the pool of potential lithium responders to continue to Phase 2 In Phase 2 lithium responders from Phase 1 enter a 6-month long-term controlled trial Every attempt is made to define responders to lithium
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT-M | US NIH GrantContract | None | httpsreporternihgovquickSearchR29MH057093 |
| R29MH057093 | NIH | None | None |