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OpenTrials
Completed

NCT Number: NCT01195363

Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

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.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Depression Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine SR

Drug

quetiapine SR, dose range 200-600mg, each night QHS for 6mos

Other names: Seroquel SR

quetiapine sr placebo

Drug

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

Primary outcomes

  1. Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.

    Time frame: Baseline visit to week 24

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Sep 6, 2010
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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