DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: quetiapine SR (Drug); quetiapine sr placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The University of Texas Health Science Center at San Antonio

Official(s) and/or principal investigator(s):
Charles Bowden, MD, Principal Investigator, Affiliation: University of Texas

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.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

The University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States
Additional Information

Starting date: April 2007
Last updated: August 6, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017