Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder

NCT01195363 | Completed Phase 4 Results DMC

• 1 other identifier: HSC20070253H
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

bipolar disorder, mania, depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

quetiapine SR

ACTIVE COMPARATOR

quetiapine SR, 200-600mg, po, qd

Drug: quetiapine SR

quetiapine sr Placebo

PLACEBO COMPARATOR

quetiapine SR placebo, 200-600mg, po qd

Drug: quetiapine sr placebo

Interventions

quetiapine SR DRUG

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

Also known as: Seroquel SR

quetiapine SR

quetiapine sr placebo DRUG

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

quetiapine sr Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• AstraZeneca: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania; Depression

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Overall limitations were screen failures and lost to follow-ups which led to not reaching recruitment goals.

Results Point of Contact

• Title: Charles L Bowden, MD
• Organization: UTHSCSA

BowdenC@uthscsa.edu

210-567-5393

Study Officials

• Charles Bowden, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 6, 2010
• Study Start: April 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: March 23, 2017
• Results First Posted: February 12, 2015

Record last verified: 2017-03

Locations

US (1)