Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

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