A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study

NCT01254721 | Terminated Phase 4 Results

• 1 other identifier: D1443L00086
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using the last observation carried forward method.

Conditions

Acute Bipolar Mania

Keywords

Acute bipolar mania; Seroquel XR; Seroquel XR plus lithium; Quetiapine fumarate

Outcome Measures

Primary Outcomes (1)

• The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29

  The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.

  From Baseline to Day 29

Secondary Outcomes (1)

• The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)

  From Baseline to Day 29

Study Arms (2)

1

EXPERIMENTAL

Seroquel XR tablet

Drug: Quetiapine fumarate

2

ACTIVE COMPARATOR

Seroquel XR + lithium

Drug: Quetiapine fumarate; Drug: lithium

Interventions

Quetiapine fumarate DRUG

eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study.

1; 2

lithium DRUG

300mg tablet, oral

2

Eligibility Criteria

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

You may qualify if:

• Female and/or male inpatients or outpatients, aged over 18 years and under 65 years
• Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
• YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic.
• Female patients must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive

You may not qualify if:

• Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline
• Known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Research Site

Ansan, Gyeonggi-do, South Korea

Location

Research Site

Daegu, Gyeongsangbuk-do, South Korea

Location

Research Site

Jinju, Gyeongsangnam-do, South Korea

Location

Research Site

Pusan, Gyeongsangnam-do, South Korea

Location

Research Site

Seoul, Seoul, South Korea

Location

MeSH Terms

Interventions

Quetiapine Fumarate; Lithium

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Results Point of Contact

• Title: Hui Jung Sin / Clinical Project Leader
• Organization: SM&M Korea

ClinicalTrialTransparency@astrazeneca.com

82-2-2188-2165

Study Officials

• Yeon Ho Joo

  Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 8, 2014
• Results First Posted: May 8, 2014

Record last verified: 2014-04

Locations

KR (5)