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

Bipolar I Disorder Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01495156
• Other study ID #: 11-185
• Status: Withdrawn
• Phase: Phase 4
• First received: November 22, 2011
• Last updated: January 21, 2014
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: January 2014
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

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/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.

Locations

Country	Name	City	State
United States	The Zucker Hillside Hospital, North Shore-LIJ Health System	Glen Oaks	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute phase :Time to partial or full response	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."	8 weeks	No
Primary	Continuation Phase: time to recurrence of a subsyndromal mood episode	We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase	24 weeks	Yes
Secondary	Acute phase: number of suicidal events		8 weeks	Yes
Secondary	Acute phase: positive urine toxicology screens (yes/no variable)		8 weeks	Yes
Secondary	Acute phase: adherence to medication regimen.		8 weeks	No