Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195363
• Other study ID #: HSC20070253H
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2010
• Last updated: March 21, 2017
• Start date: April 2007
• Est. completion date: June 2011

Study information

• Verified date: March 2017
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Drug:
• quetiapine SR
quetiapine SR, dose range 200-600mg, each night QHS for 6mos
• quetiapine sr placebo
quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.	The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.	Baseline visit to week 24