Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.

NCT00521365 | Completed Phase 4 Results

• 1 other identifier: D1443L00017
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 7

Brief Summary

The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.

Conditions

Bipolar Disorder; Bipolar Affective Psychosis; Mania; Manic Disorder; Manic State

Keywords

Bipolar Disorder; Bipolar Affective Psychosis; Mania; Manic Disorder; Manic State

Outcome Measures

Primary Outcomes (1)

• Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)

  Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.

  Baseline and 3 weeks

Secondary Outcomes (13)

• Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.

  Baseline and 1 week

• Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3

  Baseline and 2 weeks

• Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)

  21 days ± 2 days or Last Observation Carried Forward

• Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).

  21 days ± 2 days or Last Observation Carried Forward

• Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).

  Baseline and 3 weeks

Study Arms (1)

Quetapine 600 mg

EXPERIMENTAL

Drug: Quetiapine 600mg

Interventions

Quetiapine 600mg DRUG

300 mg quetiapine fumarate tablets for oral use. Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.

Quetapine 600 mg

Eligibility Criteria

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

You may qualify if:

• Patients with type I Bipolar Disorder in Manic phase according to standard scales and physician criteria.
• Patients of both genders, aged 18-65 years old being at the first episode

You may not qualify if:

• Psychoactive substance or alcohol abuse or dependence, forbidden medication, pregnancy, rapid cycling patients, intolerance to Quetiapine, clinically severe disease, unstable Diabetes Mellitus, neutropenia, other laboratory abnormalities

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Guadalajara, Jalisco, Mexico

Location

Research Site

Mexico City, Mexico City, Mexico

Location

Research Site

Monterrey, Nuevo León, Mexico

Location

Research Site

San Pedro Garza García, Nuevo León, Mexico

Location

Research Site

San Luis Potosí City, San Luis Potosí, Mexico

Location

Research Site

Mérida, Yucatán, Mexico

Location

Research Site

Durango, Mexico

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Open label, non comparative study

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

09645895

Study Officials

• Ana Polanco, MD

  AstraZeneca Mexico

  STUDY DIRECTOR

• Doris Gutierrez, MD

  INP

  PRINCIPAL INVESTIGATOR

• Julieta Jimenez

  AstraZeneca

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: May 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 17, 2012
• Results First Posted: July 17, 2012

Record last verified: 2012-03

Locations

ME (7)