Etude prospective du rôle prédictif du polymorphisme fonctionnel 5-HTTLPR sur la réponse au traitement par l’escitalopram des patients souffrant d’un trouble obsessionnel compulsif

• Conditions: obsessive compulsive disorder; MedDRA version: 12.0Level: LLTClassification code 10029898Term: Obsessive-compulsive disorder

• Registration Number: EUCTR2009-016443-19-FR
• Lead Sponsor: CHU de Poitiers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- Patient suffering from an OCD with Y BOCS > 16 without other untreated axis I disorders (MINI) or to whom the current treatment is ineffective or badly tolerated.
- Age = 18 years.
- Caucasian Origin.
- Free subject, without guardianship or subordination.
- Cover of the subjects by a national insurance scheme or by benefiting through a third person in agreement with the French law on the biomedical research (Huriet Law n°88.1138 and its modifications).
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

- OCD patients suffering from other axis I disorders (MINI).
- Patients being already treated with escitalopram or paroxetine in this indication.
- Patients suffering from neurological disorder (epilepsy, encephalopathy) or cognitive disorder (memory deficit with MMSE < 26 and reminder upper to 1).
- Mental delay.
- Unstable clinical State, schizophrenia.
- Patients hospitalized in automatic Hospitalization or Hospitalization at the request of a third.
- Addictive comorbidity including alcoholism or abuse of substances
- Treatment with other psychotropic drugs (antidepressant, neuroleptic)
Patients having a contraindication of the use of escitalopram: hypersensitivity to escitalopram or excipients, association with monoamine oxydase inhibitor (IMAO, respect the delay of 14 days after the stop of an irreversible IMAO). Cautions are recommended in case of diabetes, associations with serotoninergic molecules including L-tryptophane, triptans, tramadol, linezolide, SRIs, lithium and St.-John's wort, with oral anticoagulants, with cytochromes inhibitors of the CYP2C19 isoenzyme (for example omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlodipine, cimetidine), with drugs mainly metabolized by the CYP2D6 isoenzyme (for example, flecaïnide, propafenone, metoprolol, antidepressants such as desipramine, clomipramine and nortriptyline or antipsychotics such as risperidone, thioridazine and haloperidol).
- Patients having a contraindication of the use of paroxetine: hypersensitivity to paroxetine or excipients, association with monoamine oxydase inhibitor (IMAO, respect the delay of at least 24 hours after the stop of reversible IMAO (moclobémide, linézolide) and 2 weeks after the stop of irreversible IMAO), association with thioridazine, pimozide. Cautions are recommended in case of diabetes, narrow-angle glaucoma, associations with serotoninergic molecules including L-tryptophane, triptans, tramadol, linezolide, SRIs, lithium and St.-John's wort, with oral anticoagulants, with NSAID/ acetylsalicylic acid, with drugs affecting the gastric pH (antiacids, proton pump inhibitors or histamine H2 receptor antagonists).
- Age < 18 years.
- Not Caucasian Origin.
- Under guardianship patient or guardianship without social coverage.
- Subject without social coverage.
- Woman in genital activity period without contraception.
- Persons benefiting from a strengthened protection including minors, pregnant women, breast-feeding women, people private of freedom by a court or administrative order, persons staying in a sanitary or social establishment, adults under legal protection, and finally patients in emergency situation.

Study & Design

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