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.
Overview
- Phase
- Phase 4
- Intervention
- Lithium treatment in combination with a SGA (Second Generation Antipsychotic)
- Conditions
- Bipolar I Disorder
- Sponsor
- Northwell Health
- Locations
- 1
- Primary Endpoint
- Acute phase :Time to partial or full response
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, 12-18 years old, inpatients or outpatients
- •meet DSM-IV criteria for Bipolar I disorder - manic or mixed episode
- •psychotic symptoms present
- •Exclusion criteria:
- •current serious homicidal/suicidal ideation
- •prior non-response or intolerance to an adequate trial of lithium
- •prior non-response or intolerance to adequate trials of both aripiprazole and risperidone
- •any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone
- •inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone
- •seizure disorder
Exclusion Criteria
- Not provided
Arms & Interventions
Lithium/Adjunctive SGA
Intervention: Lithium treatment in combination with a SGA (Second Generation Antipsychotic)
Placebo/Adjunctive SGA
Intervention: Placebo/Adjunctive SGA treatment
Outcomes
Primary Outcomes
Acute phase :Time to partial or full response
Time Frame: 8 weeks
Acute phase: Partial response is defined as at least a 25% -49% reduction in YMRS score and a CGI improvement item score of 2. Full response is defined as a reduction in YMRS score of 50% or more and a CGI improvement item score of 1 "very much improved."
Continuation Phase: time to recurrence of a subsyndromal mood episode
Time Frame: 24 weeks
We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase
Secondary Outcomes
- Acute phase: adherence to medication regimen.(8 weeks)
- Acute phase: number of suicidal events(8 weeks)
- Acute phase: positive urine toxicology screens (yes/no variable)(8 weeks)