Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder

NCT00672490 | Completed Phase 4 Results

• 1 other identifier: D1443L00023
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 16

Brief Summary

To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation

Conditions

Acute Mania in Bipolar Disorder

Keywords

Acute Mania; Bipolar Disorder; Quetiapine Fumarate; Lithium

Outcome Measures

Primary Outcomes (1)

• Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)

  The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).

  Baseline and 4 weeks

Secondary Outcomes (8)

• Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)

  Baseline and 4 weeks

• Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)

  Baseline and 4 weeks

• Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)

  Baseline and 4 weeks

• Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment

  Baseline and 4 weeks

• Response Rate (Number of Patients With Clinically Response)

  From Baseline to 4 weeks

Study Arms (2)

1

EXPERIMENTAL

Quetiapine Fumarate - tablets

Drug: Quetiapine Fumarate

2

EXPERIMENTAL

Quetiapine Fumarate - tablets and Lithium

Drug: Quetiapine Fumarate; Drug: Lithium

Interventions

Quetiapine Fumarate DRUG

Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator. Tablets

Also known as: Seroquel

1; 2

Lithium DRUG

Oral treatment, twice daily. 250 mg/day to 2000mg/day from Day1 to Day 7, 500mg/day to 2000mg/day thereafter, judged by the investigator.

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of written informed consent before initiation of any study related procedures. Patients who are deemed incapable of providing informed consent maybe enrolled if written informed consent has been obtained from the patient's Legally Authorized Representative.
• Documented clinical diagnosis meeting the DSM-IV criteria for any of the following:
• X Bipolar I Disorder, Most Recent Episode Manic
• X Bipolar I Disorder, Single Manic Episode
• Have a YMRS score of at least 20 and a score of at least 4 on 2 of the following 4 YMRS items both at enrolment and at randomisation: Irritability, Speech, Content, and Disruptive/Aggressive Behaviour.
• Female patients of childbearing potential must have a negative urine pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e., barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation, during the study.
• Be able to understand and comply with the requirements of the study, as judged by the investigator.

You may not qualify if:

• Manic episode judged to be either:
• the direct physiological consequence of a treatment or medical condition other than Bipolar disorder.
• the direct physiological effect of a substance of abuse; intoxication with hallucinogens, inhalants, opioids, or phencyclidine and related substances.
• the direct physiological effect of psychostimulant or antidepressant medication.
• Evidence of clinically severe or active disease, or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication.
• History of seizure disorder, except febrile convulsions.
• Hospitalization period of 3 weeks or longer immediately prior to randomization for the index manic episode.
• Known history of intolerance or hypersensitivity to quetiapine or lithium, or to any other component in the tablets/capsules.
• Known lack of response to quetiapine or lithium, as judged by the investigator.
• Use of antipsychotic medication or mood stabilizer other than quetiapine and lithium at the day of randomisation (to be tapered to discontinuation between the enrolment visit and randomisation).
• Administration of a depot antipsychotic injection within 1 dosing interval (for the depot) before randomisation.
• Use of clozapine within 28 days prior to randomisation.
• Use of antidepressants during the enrolment period or within a period of 5 half-lives of the drug(s) prior to randomisation.
• Continuous daily use of benzodiazepines in excess of 4 mg per day of lorazepam, or the equivalent, during 28 days prior to randomisation.
• Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes within 14 days before randomisation.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (16)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Baoding, Hebei, China

Location

Research Site

Shijiazhuang, Hebei, China

Location

Research Site

Daqing, Heilongjiang, China

Location

Research Site

Xinxiang, Henan, China

Location

Research Site

Wuhan, Hubei, China

Location

Research Site

Suzhou, Jiangsu, China

Location

Research Site

Shenyang, Liaoning, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Xijing, Shanxi, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Tianjin, Tianjin Municipality, China

Location

Research Site

Kuming, Yunnan, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Research Site

Huzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate; Lithium

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

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: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Zhang Hongyan, Prof.

  Peking University 6th hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: May 2, 2008
• First Posted: May 6, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 12, 2012
• Results First Posted: July 12, 2012

Record last verified: 2012-06

Locations

CN (16)