Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

Completed · Phase 4 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT01195363

Run by

The University of Texas Health Science Center at San Antonio

People needed

28

Starts

2007-04-01

Expected to finish

2011-06-01

Last updated by the study team

2017-03-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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