Major Depressive Episode in Bipolar Disorder MedDRA version: 9.1 Level: LLT Classification code 10004908 Term: Bipolar affective disorder
Conditions
Interventions
Trade Name: DAPAROX*28CPR RIV 20MG PVC/PE/
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Paroxetine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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 ≤ 50% baseline) and/or remission (HAM-D ≤ 7) 2.Percentage of subjects with a YMRS score ≥ 12 at the end of the study 3.Changes in SF-36 scores at 4 and 12 weeks | — |
Countries
Italy
Outcome results
None listed