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

Primary Purpose

Bipolar I Disorder

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lithium treatment in combination with a SGA (Second Generation Antipsychotic)

Placebo/Adjunctive SGA treatment

About this trial

This is an interventional treatment trial for Bipolar I Disorder

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Zucker Hillside Hospital, North Shore-LIJ Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lithium/Adjunctive SGA

Placebo/Adjunctive SGA

Arm Description

Outcomes

Primary Outcome Measures

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."

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

Secondary Outcome Measures

Acute phase: number of suicidal events

Acute phase: positive urine toxicology screens (yes/no variable)

Acute phase: adherence to medication regimen.

Full Information

NCT ID

NCT01495156

First Posted

November 22, 2011

Last Updated

January 21, 2014

Sponsor

Northwell Health

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT01495156

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Withdrawn

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwell Health

Collaborators

National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar I Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lithium/Adjunctive SGA

Arm Type

Experimental

Arm Title

Placebo/Adjunctive SGA

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Lithium treatment in combination with a SGA (Second Generation Antipsychotic)

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo/Adjunctive SGA treatment

Intervention Description

Primary Outcome Measure Information:

Title

Acute phase :Time to partial or full response

Description

Time Frame

8 weeks

Title

Continuation Phase: time to recurrence of a subsyndromal mood episode

Description

We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Acute phase: number of suicidal events

Time Frame

8 weeks

Title

Acute phase: positive urine toxicology screens (yes/no variable)

Time Frame

8 weeks

Title

Acute phase: adherence to medication regimen.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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.

Facility Information:

Facility Name

The Zucker Hillside Hospital, North Shore-LIJ Health System

City

Glen Oaks

State/Province

New York

ZIP/Postal Code

11004

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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