Status:
COMPLETED
Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
AstraZeneca
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01195363
Start Date
April 1 2007
End Date
June 1 2011
Last Update
March 23 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229