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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Bipolar I Disorder
Drug: Lithium treatment in combination with a SGA (Second Generation Antipsychotic)
Drug: Placebo/Adjunctive SGA treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lithium/Adjunctive SGA 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).

Placebo Comparator: Placebo/Adjunctive SGA 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.


  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495156

Locations
United States, New York
The Zucker Hillside Hospital, North Shore-LIJ Health System
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01495156     History of Changes
Other Study ID Numbers: 11-185
Study First Received: November 22, 2011
Last Updated: January 21, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lithium
Antipsychotic Agents
Lithium Carbonate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014