Paroxetine or Quetiapine in Addition to Mood Stabilizers in Bipolar Depression - ND

Active, not recruiting

Conditions: Major Depressive Episode in Bipolar Disorder
MedDRA version: 9.1Level: LLTClassification code 10004908Term: Bipolar affective disorder

Registration Number: EUCTR2009-011253-40-IT

Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Age ≥ 18 years
2. Read understood and signed the informed consent
3. Diagnosis of Bipolar Disorder, Major Depressive Episode diagnosed by means of MINI 5.0.0.
4. Treatment with lithium or valproate in previous 2 months, with lithium levels 0.6-1.2 mEq/L or valproate levels 50-130 ug/ml at baseline
5.HAM-D ≥ 18
6.YMRS ≤ 12
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Severe or unstable medical conditions
2. Pregnancy or non-utilization of contraceptives;
3. Suicide ideation or HAMD item 3 ≥ 3
4. Rapid cycling bipolar disorder
5. Another principal DSM-IV TR Axis I disorder
6. Non response or intollerance to paroxetine or quetiapine

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To evaluate the efficacy of paroxetine or quetiapine addition on depressive symptoms in patients with a bipolar disorder and a major depressive episode during therapy with mood stabilizer (lithium or valproate);Secondary Objective: 1.To evaluate the risk of switch into mania during the treatment with paroxetine or quetiapine in addition to a mood stabilizer.<br>2.To evaluate change in quality of life associated to paroxetine or quetiapine in patients with bipolar disorder and a current major depressive episode during the treatment with a mood stabilizer (lithium or valproate);Primary end point(s): 1.Mean reduction of the HAM-D scale score; percentage of subjects who obtain a response (HAM-D &#8804; 50% baseline) and/or remission (HAM-D &#8804; 7) <br>2.Percentage of subjects with a YMRS score &#8805; 12 at the end of the study<br>3.Changes in SF-36 scores at 4 and 12 weeks

Secondary Outcome Measures