Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)

Not Applicable

• Conditions: -F319 Bipolar affective disorder, unspecified; Bipolar affective disorder, unspecified; F319

• Registration Number: PER-010-05
• Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Provide written informed consent before initiating any procedure
2) A diagnosis of Bipolar I Disorder, Most Recent Manic Episode, Bipolar I Disorder, Most Recent Depressive Episode or Bipolar I Disorder, Most Recent Mixed Episode, with or without psychotic features
3) Male or female> 18 years of age.
4) At least 1 manic, depressive or mixed episode in the previous 2 years
5) One of the following:
a) A current manic, depressive or mixed episode, according to the DSM-IV criteria
b) A manic, depressive or mixed episode in the previous 26 weeks
6) Women of childbearing age should be using a reliable method of contraception.
7) Able to understand and comply with the requirements of the study.

Exclusion Criteria

1) Diagnosis of anxiety disorder.
2) Known intolerance or lack of response to quetiapine or lithium fumarate.
3) Pregnancy or lactation: women of childbearing age must have a negative test for human chorionic gonadotrophin (HCG) in serum.
4) Substance or alcohol dependence.
5) Abuse of opiates, amphetamine, barbiturates, cocaine, cannabinoids or hallucinogens.
6) Use of any of the cytochrome P450 3A4 inhibitors in the 14 days prior to enrollment.
7) Use of any of the inducers of cytochrome P450 3A4 in the 14 days prior to enrollment.
8) Concentration of thyroid stimulating hormone (TSH) greater than 10% above the upper limit
9) Unstable or inadequately treated medical disease
10) Patient with unstable Diabetes Mellitus (DM), untreated or with other conditions that prevent him from participating in the study
11) Medical conditions that would affect the absorption, distribution, metabolism or excretion of the treatment
12) Use of an experimental drug within 30 days prior to enrollment.
13) Patient previously enrolled in this study, study D1447C00126 or study D1447C00127.
14) Patient who participates in the programming and conduction of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation: Recurrence will be confirmed by at least 1 of the following criteria: 1) Start of an antipsychotic, antidepressant, mood stabilizer other than the assigned mood stabilizer, anxiolytic other than lorazepam or any other medication to treat a manic, depressive event or mixed. 2) Hospitalization due to a manic, depressive or mixed event. 3) Young mania classification scale (YMRS)> 20 in 2 consecutive evaluations or in the final evaluation. 4) Discontinuation of a study patient if, according to the investigator s criteria, the discontinuation was due to a manic, depressive or mixed event.<br>Measure:Recurrence time of an affective episode.<br>Timepoints:Open phase, weeks: 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24.<br>Randomized phase, weeks: 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 68, 76, 84, 92, 104.<br>