Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | April 2007 |
| End Date: | June 2011 |
A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder
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.
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.
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
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
Click here to add this to my saved trials
