Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

Study Overview
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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.

Official Title
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A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: quetiapine SR
* Drug: quetiapine sr placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: quetiapine SR<br>quetiapine SR, 200-600mg, po, qd | Drug: quetiapine SR<br>* quetiapine SR, dose range 200-600mg, each night QHS for 6mos<br>* Other names: Seroquel SR;|
| Placebo Comparator: quetiapine sr Placebo<br>quetiapine SR placebo, 200-600mg, po qd | Drug: quetiapine sr placebo<br>* quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores. | The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms. | Baseline visit to week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar disorder, mania, depression