Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: quetiapine SR

Drug: quetiapine sr placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01195363

HSC20070253H

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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