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

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ClinicalTrials.gov Identifier: NCT01495156
Recruitment Status : Withdrawn
First Posted : December 19, 2011
Last Update Posted : January 22, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Northwell Health

Tracking Information
First Submitted Date  ICMJE November 22, 2011
First Posted Date  ICMJE December 19, 2011
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01495156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2011)
  • Acute phase: number of suicidal events [ Time Frame: 8 weeks ]
  • Acute phase: positive urine toxicology screens (yes/no variable) [ Time Frame: 8 weeks ]
  • Acute phase: adherence to medication regimen. [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bipolar I Disorder
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 21, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2011)
40
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01495156
Other Study ID Numbers  ICMJE 11-185
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account Northwell Health
Verification Date January 2014

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