Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 1:12 PM
Study NCT ID:
NCT01495156
Status:
WITHDRAWN
Last Update Posted:
2014-01-22
First Post:
2011-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
Sponsor:
Northwell Health
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Adjunctive Lithium for the Treatment of Psychotic Mania Followed by an Open Label Long-term Safety Period.
Status:
WITHDRAWN
Status Verified Date:
2014-01
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:
The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium.
The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.
The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: