NCT00579280

Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD

A Randomized, Double-blind, Placebo-controlled Study of Quetiapine SR and Divalproex Sodium ER on Anxiety in Bipolar Disorder With at Least Moderately Severe Current Anxiety and Lifetime Panic or Generalized Anxiety Disorder.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.

Detailed description

This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of quetiapine SR monotherapy compared to divalproex sodium ER monotherapy in outpatient subjects with a lifetime bipolar I, II, or not otherwsise specified (NOS) disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 180 subjects will be randomized to obtain 90 subjects who complete the 8-week trial (30 completers per treatment group). This calculation is based on drop out rates in a similar patient population carried out by this group of collaborators. Subjects will be randomized to quetiapine SR or divalproex sodium ER or placebo in a 1:1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of extrapyramidal side effects (EPS). Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.

Conditions

• Bipolar Disorder
• Panic Disorder
• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	quetiapine SR	flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks
DRUG	divalproex sodium ER	Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks
DRUG	placebo	placebo

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-12-24
• Last updated: 2020-06-11
• Results posted: 2020-06-11

Locations

3 sites across 1 country: United States