Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-06-30

Brief Summary

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To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.

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Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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quetiapine SR

quetiapine SR, 200-600mg, po, qd

Group Type ACTIVE_COMPARATOR

quetiapine SR

Intervention Type DRUG

quetiapine SR, dose range 200-600mg, each night QHS for 6mos

quetiapine sr Placebo

quetiapine SR placebo, 200-600mg, po qd

Group Type PLACEBO_COMPARATOR

quetiapine sr placebo

Intervention Type DRUG

quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos

Interventions

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quetiapine SR

quetiapine SR, dose range 200-600mg, each night QHS for 6mos

Intervention Type DRUG

quetiapine sr placebo

quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos

Intervention Type DRUG

Other Intervention Names

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Seroquel SR

Eligibility Criteria

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Inclusion Criteria

* Male or female;
* Age 18 years and older
* Patients on:

* Li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5 mEq/l OR
* DIV dose for 4 weeks or longer, and a serum level at screening of 45 g/ml OR
* LAM (dosage/day ≥100mg) at a stable dose for 4 weeks or longer OR
* Any combination 3a, 3b, or 3c
* Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
* Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score\>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score\>/=14
* Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score\>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score\>/=14 ;
* Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score\>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score\>/=14

Exclusion Criteria

* Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or AIDS induced mania
* Women with a positive pregnancy test or who are lactating
* Women of child-bearing potential who are not practicing a clinically accepted method of contraception
* Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
* Patients whose clinical status requires inpatient or day hospital treatment
* History of severe side effects associated with therapeutic doses of Li, DIV, LAM
* Alcohol or drug dependent at time of enrollment
* Suicidal at time of enrollment.
* Current or previous exposure to QTP

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No