Evaluation of pharmacokinetic and pharmacodynamic interactions between escitalopram and drugs used for the treatment of bipolar disorders. - ND

• Conditions: bipolar disorders; MedDRA version: 9.1Level: LLTClassification code 10057667Term: Bipolar disorder

• Registration Number: EUCTR2008-000370-20-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.