Who is sponsoring NCT01195363?

NCT01195363 is sponsored by The University of Texas Health Science Center at San Antonio.

What condition does NCT01195363 study?

NCT01195363 studies Bipolar Disorder.

What drugs are being tested in NCT01195363?

Interventions: quetiapine SR, quetiapine sr placebo.

What is the status of NCT01195363?

NCT01195363 is currently COMPLETED.

Last reviewed 2017-03-21 · How we verify

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

NCT01195363 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	The University of Texas Health Science Center at San Antonio
Phase	Phase 4
Status	COMPLETED
Enrolment	28
Start date	2007-04
Completion	2011-06

Conditions

Bipolar Disorder

Interventions

quetiapine SR
quetiapine sr placebo

Primary outcomes

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

Countries

United States