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Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01495156
First received: November 22, 2011
Last updated: January 21, 2014
Last verified: January 2014

November 22, 2011
January 21, 2014
September 2011
September 2014   (final data collection date for primary outcome measure)
  • Acute phase :Time to partial or full response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase
Same as current
Complete list of historical versions of study NCT01495156 on ClinicalTrials.gov Archive Site
  • Acute phase: number of suicidal events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Acute phase: positive urine toxicology screens (yes/no variable) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Acute phase: adherence to medication regimen. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Bipolar I Disorder
  • Drug: Lithium treatment in combination with a SGA (Second Generation Antipsychotic)

    All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg.

    Subjects in the lithium /adjunctive SGA group will be started at 900 mg/day lithium in thrice daily dosing. The lithium dose will be increased to 1200mg/day on day 4 if lithium has been well-tolerated and symptoms of mania remain, as determined by a phone assessment done by a blinded study physician. The target serum level of lithium will be 1.2 mEq/L (range 0.8 to 1.4 mEq/L).

  • Drug: Placebo/Adjunctive SGA treatment

    All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg.

    Subjects in the placebo /adjunctive SGA group will receive placebo for the entire trial in addition to the adjunctive SGA.

  • Experimental: Lithium/Adjunctive SGA
    Intervention: Drug: Lithium treatment in combination with a SGA (Second Generation Antipsychotic)
  • Placebo Comparator: Placebo/Adjunctive SGA
    Intervention: Drug: Placebo/Adjunctive SGA treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2015
September 2014   (final data collection date for primary outcome measure)

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
  • pregnant or, if sexually active, not using birth control, such as oral contraceptives, two barrier methods, long-acting depot preparations or an intra-uterine device
  • Full Scale IQ less than 70
  • meets criteria for a DSM-IV diagnosis of substance-induced mood disorder or mood disorder due to a general medical condition.
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01495156
11-185
No
North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
National Institutes of Health (NIH)
Not Provided
North Shore Long Island Jewish Health System
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP