Clinical trial NCT01195363: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: bipolar disorder, mania, depression
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2010-09-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
timeFrame: Baseline visit to week 24
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas
name: Charles Bowden, MD
role: PRINCIPAL_INVESTIGATOR
References: