bipolar disorders MedDRA version: 9.1 Level: LLT Classification code 10057667 Term: Bipolar disorder
Conditions
Interventions
Trade Name: CIPRALEX
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Escitalopram
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Lam
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients Age between 18 and 70 years Patients candidate to receive escitalopram for major depressive episodes, depressive episodes, panic, anxiety or obsessive-compulsive symptoms. Patients treated with: lamotrigine, valproic acid, carbamazepine, oxcarbazepine, gabapentin, levetiracetam, and lithium. Those drugs will be prescribed and administered at doses indicated. Patients with adequate bone marrow, liver and renal function. Patients able to provide a Written Informed Consent. 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: Patients younger than 18 or older than 70 years Patients treated with antipsychotics. Patients need to be treated with antidepressant other than study drug. Patients who will not be able to attend the follow up visits Patients with poor compliance Patients who scored ≥2 at item 3 on HAMD Pregnancy or breast feeding Premenopausal female patients who do not use contraceptives Substance abuse or dependence within the last year A diagnosis of renal or liver failure, jaundice, cardiopathy or severe lung diseases, hematological diseases and past episodes of photosensibilization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate pharmacokinetic and pharmacodynamic interactions between escitalopram and drugs used for the treatment of bipolar mood disorders.;Secondary Objective: To evaluate possible correlations between drug plasma concentrations and treatment tolerability. To assess any possible influence of patient?s genotype on drug kinetics, efficacy and tolerability;Primary end point(s): to measure plasma concentrations of drug administered for the treatment of bipolar disorders before and after administering escitalopram, and plasma levels of escitalopram and its active metabolite desmethylcitalopram. | — |
Countries
Italy
Outcome results
None listed