Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00081380

Collaborator

(none)

710

Enrollment

Locations

Duration (Months)

7.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Seroquel®, quetiapine fumarate (atypical antipsychotic) Drug: lithium (mood stabilizer) Drug: divalproex (mood stabilizer)	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)

Study Start Date :

Mar 1, 2004

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event. []

Secondary Outcome Measures

Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Open-Label

A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
Able to understand and comply with the requirements of the study.

Exclusion Criteria:

Open-Label

Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
Previously randomized into this study or D1447C00126

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Scottsdale	Arizona	United States
3	Research Site	Little Rock	Arkansas	United States
4	Research Site	Anaheim	California	United States
5	Research Site	Cerritos	California	United States
6	Research Site	Chula Vista	California	United States
7	Research Site	Culver City	California	United States
8	Research Site	Garden Grove	California	United States
9	Research Site	La Mesa	California	United States
10	Research Site	Oceanside	California	United States
11	Research Site	Orange	California	United States
12	Research Site	Pico Rivera	California	United States
13	Research Site	Riverside	California	United States
14	Research Site	Rosemead	California	United States
15	Research Site	San Diego	California	United States
16	Research Site	San Francisco	California	United States
17	Research Site	Santa Ana	California	United States
18	Research Site	Farmington	Connecticut	United States
19	Research Site	New Britain	Connecticut	United States
20	Research Site	Jacksonville	Florida	United States
21	Research Site	Miami	Florida	United States
22	Research Site	Orlando	Florida	United States
23	Research Site	West Palm Beach	Florida	United States
24	Research Site	Winter Park	Florida	United States
25	Research Site	Atlanta	Georgia	United States
26	Research Site	Decatur	Georgia	United States
27	Research Site	Marietta	Georgia	United States
28	Research Site	Smyrna	Georgia	United States
29	Research Site	Honolulu	Hawaii	United States
30	Research Site	Chicago	Illinois	United States
31	Research Site	Hoffman Estates	Illinois	United States
32	Research Site	Joliet	Illinois	United States
33	Research Site	Evansville	Indiana	United States
34	Research Site	Greenwood	Indiana	United States
35	Research Site	Indianapolis	Indiana	United States
36	Research Site	Wichita	Kansas	United States
37	Research Site	Florence	Kentucky	United States
38	Research Site	Lake Charles	Louisiana	United States
39	Research Site	New Orleans	Louisiana	United States
40	Research Site	Shreveport	Louisiana	United States
41	Research Site	Baltimore	Maryland	United States
42	Research Site	Rockville	Maryland	United States
43	Research Site	Pittsfield	Massachusetts	United States
44	Research Site	New Baltimore	Michigan	United States
45	Research Site	St. Louis	Missouri	United States
46	Research Site	Clementon	New Jersey	United States
47	Research Site	Moorestown	New Jersey	United States
48	Research Site	West Caldwell	New Jersey	United States
49	Research Site	Albuquerque	New Mexico	United States
50	Research Site	Bronx	New York	United States
51	Research Site	Brooklyn	New York	United States
52	Research Site	New York	New York	United States
53	Research Site	Butner	North Carolina	United States
54	Research Site	Raleigh	North Carolina	United States
55	Research Site	Beachwood	Ohio	United States
56	Research Site	Cincinnati	Ohio	United States
57	Research Site	Dayton	Ohio	United States
58	Research Site	Medina	Ohio	United States
59	Research Site	Oklahoma City	Oklahoma	United States
60	Research Site	Tulsa	Oklahoma	United States
61	Research Site	Eugene	Oregon	United States
62	Research Site	Portland	Oregon	United States
63	Research Site	Emmaus	Pennsylvania	United States
64	Research Site	Moon Township	Pennsylvania	United States
65	Research Site	Philadelphia	Pennsylvania	United States
66	Research Site	Charleston	South Carolina	United States
67	Research Site	Memphis	Tennessee	United States
68	Research Site	Austin	Texas	United States
69	Research Site	Dallas	Texas	United States
70	Research Site	DeSoto	Texas	United States
71	Research Site	Houston	Texas	United States
72	Research Site	Irving	Texas	United States
73	Research Site	San Antonio	Texas	United States
74	Research Site	Wichita Falls	Texas	United States
75	Research Site	Charlottesville	Virginia	United States
76	Research Site	Falls Church	Virginia	United States
77	Research Site	Richmond	Virginia	United States
78	Research Site	Virginia Beach	Virginia	United States
79	Research Site	Bellevue	Washington	United States
80	Research Site	Kirkland	Washington	United States
81	Research Site	Morgantown	West Virginia	United States
82	Research Site	Edmonton	Alberta	Canada
83	Research Site	Vancouver	British Columbia	Canada
84	Research Site	Victoria	British Columbia	Canada
85	Research Site	Winnipeg	Manitoba	Canada
86	Research Site	Halifax	Nova Scotia	Canada
87	Research Site	Hamilton	Ontario	Canada
88	Research Site	Kingston	Ontario	Canada
89	Research Site	Markham	Ontario	Canada
90	Research Site	Mississauga	Ontario	Canada
91	Research Site	Oshawa	Ontario	Canada
92	Research Site	Toronto	Ontario	Canada
93	Research Site	Montreal	Quebec	Canada
94	Research Site	Quebec		Canada