Who is sponsoring NCT00671853?

NCT00671853 is sponsored by University Hospitals Cleveland Medical Center.

What condition does NCT00671853 study?

NCT00671853 studies Bipolar Disorder, Anxiety, Anxiety Disorders, Substance Use Disorders.

What drugs are being tested in NCT00671853?

Interventions: Quetiapine XR, Placebo for quetiapine XR.

What is the status of NCT00671853?

NCT00671853 is currently COMPLETED.

Last reviewed 2016-11-09 · How we verify

Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder

NCT00671853 Phase 3 COMPLETED Results posted

The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The secondary aim is to generate an estimate of effect size to power a definitive large-scale, multi-site collaborative R01 and to configure the use of the primary and secondary outcome measures in the definitive large-scale study.

Details

Lead sponsor	University Hospitals Cleveland Medical Center
Phase	Phase 3
Status	COMPLETED
Enrolment	120
Start date	2008-04
Completion	2011-03

Conditions

Bipolar Disorder
Anxiety
Anxiety Disorders
Substance Use Disorders

Interventions

Quetiapine XR
Placebo for quetiapine XR

Primary outcomes

Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score — Week 0 - Week 8
A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression.

Countries

United States