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Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
quetiapine SR
quetiapine sr placebo
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, mania, depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

quetiapine SR

quetiapine sr Placebo

Arm Description

quetiapine SR, 200-600mg, po, qd

quetiapine SR placebo, 200-600mg, po qd

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2010
Last Updated
March 21, 2017
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01195363
Brief Title
Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder
Official Title
A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 group of patients with an index episode of a mixed state in BD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar disorder, mania, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quetiapine SR
Arm Type
Active Comparator
Arm Description
quetiapine SR, 200-600mg, po, qd
Arm Title
quetiapine sr Placebo
Arm Type
Placebo Comparator
Arm Description
quetiapine SR placebo, 200-600mg, po qd
Intervention Type
Drug
Intervention Name(s)
quetiapine SR
Other Intervention Name(s)
Seroquel SR
Intervention Description
quetiapine SR, dose range 200-600mg, each night QHS for 6mos
Intervention Type
Drug
Intervention Name(s)
quetiapine sr placebo
Intervention Description
quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos
Primary Outcome Measure Information:
Title
Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
Description
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.
Time Frame
Baseline visit to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Bowden, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

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