Seroquel in Bipolar Depression Versus SSRI EMBOLDEN II

Not Applicable

• Conditions: -F31; F31

• Registration Number: PER-062-05
• Lead Sponsor: ASTRAZENECA - PERU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-07
• 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 related to the study.
2. Male and female patients from 18 to 65 years of age.
3. Documented clinical diagnosis for bipolar I disorder or bipolar II disorder.
4. A total score> 20 on the HAM-D scale (of 17 items) and a score> 2 on item 1 of the HAM-D scale (depressed mood).
5. Be able to understand and comply with the requirements of the study.
6. Ambulatory status.

Exclusion Criteria

1. Patients with a current Axis I disorder according to the DSM-IV.
2. Total score> 12 on the YMRS scale.
3. Patients with more than 8 episodes related to mood during the last 12 months.
4. Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrollment.
5. History of lack of response to adequate treatment with
more than 2 kinds of antidepressants during his current episode.
6. Dependence or abuse of substances / alcohol.
7. Use of drugs that induce or inhibit hepatic enzymes of cytochrome P450 3A4 metabolism within 2 weeks prior to randomization.
8. Use of the following medications: a) antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic or other psychoactive dogas within 5 days prior to randomization. b) fluoxetine within 28 days prior to randomization c) risperidone prolonged release within 14 days prior to randomization d) an injection of a depot antipsychotic within a dosing interval e) lithium within 7 days prior to randomization f) irreversible inhibitors of monoamine oxidase within 14 days prior to randomization.
9. Patients who will require formalized psychotherapy.
10. Patients who present a serious current risk of suicide or homicide, have a score of 3 or more on item 3 of the HAM-D scale, or have made a suicide attempt within the last 6 months.
11. Pregnancy or lactation. Female patients of childbearing age should obtain a negative result on the serum pregnancy test at enrollment and should be willing to use a reliable method of birth control.
12. A patient with uncontrolled Diabetes Mellitus.
13. Clinically important deviation of the reference range in the results of the clinical laboratory analysis.
14. Evidence of clinically relevant disease or clinical finding that is unstable.
15. Patient with renal impairment or liver failure.
16. A concentration of thyroid stimulating hormone (TSH) greater than 10% above the upper limit of the normal range.
17. Result of ECG that is considered clinically significant.
18. Patients with a history of noncompliance.
19. History of idiopathic orthostatic hypotension, or conditions that would predispose patients to hypotension.
20. Known history of intolerance or hypersensitivity to quetiapine or paroxetine or to any of the components of the tablets or capsules.
21. Lack of known response to quetiapine or paroxetine.
22. Contraindications as detailed in the country-specific prescription information for quetiapine or paroxetine.
23. Participation in another drug study within 30 days prior to enrollment in this study.
24. Participation in the planning and conduct of the study.
25. Previous enrollment or randomization of treatment in the present study. Previous participation in this study or in studies D1447C00135 or D1447C00001.
26. A score> 12 on the MADRS scale or> 12 on the YMRS scale in Week 8.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Scales: MADRS, HAM-D, CGI-BP and CGI-BP-C.<br>Measure:Primary efficacy: Reduction of the severity of bipolar disorder. Reduction of depressive symptoms.<br><br>Timepoints:Day 1 and weeks 2, 3, 4, 5, 6, 7 and 8.<br>