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Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Vivek Singh, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01195363
First received: September 2, 2010
Last updated: February 27, 2013
Last verified: February 2013
  Purpose
  1. 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.
  2. To assess background, baseline features, and behavioral components which characterize treatment response/non-response in the acute and long term management of MS

Condition Intervention Phase
Mixed-manic State of Bipolar Disorder
Drug: quetiapine SR
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • assess efficacy of quetiapine SR adjunct to mood stabilizer in mixed states [ Time Frame: 6mos ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2007
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: quetiapine SR
Atypical antipsychotic quetiapine versus placebo
Drug: quetiapine SR
quetiapine SR pills, range 200-600mg, each night QHS for 6mos
Other Name: Seroquel SR
Active Comparator: Placebo
quetiapine SR versus placebo in the treatment of mixed mania in bipolar disorder
Other: placebo
placebo, 1 pill per day for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195363

Locations
United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
AstraZeneca
Investigators
Principal Investigator: Vivek Singh, MD University of Texas
  More Information

No publications provided

Responsible Party: Vivek Singh, Principal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01195363     History of Changes
Other Study ID Numbers: HSC20070253H
Study First Received: September 2, 2010
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
bipolar disorder, mania, depression

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014