obsessive compulsive disorder MedDRA version: 12.0 Level: LLT Classification code 10029898 Term: Obsessive-compulsive disorder
Conditions
Interventions
Trade Name: SEROPLEX 10mg et 20mg
Product Name: SEROPLEX
Pharmaceutical Form: Tablet
Trade Name: DEROXAT 20mg
Product Name: DEROXAT
Pharmaceutical Form: Tablet
Sponsors
CHU de Poitiers
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the predictive character of the 5-HTTLPR functional polymorphism in the answer to the treatment with escitalopram in patients suffering from OCD;Primary end point(s): The criteria is the answer to escitalopram after 12 weeks of treatment. A patient is considered as "responder" in case of improvement of OCD estimated by a reduction of the initial score of Y BOCS = 25 %. ;Secondary Objective: - To determine prevalency of LL, SS, LS genotypes of 5-HTTLPR, CYP2C19*2 and CYP2C19*17. - To evaluate the answer to escitalopram after 12 weeks of treatment according to CYP2C19 polymorphisms (CYP2C19*2 and CYP2C19*17 in particular). - To evaluate the clinical answer after 24 weeks of escitalopram treatment in subjects responding to this drug after 12 weeks, according to the 5-HTTLPR polymorphism. - To evaluate after 24 weeks, the answer to the treatment of second intention with paroxetine, prescribed at the patients not answering to escitalopram after 12 weeks, according to the 5-HTTLPR polymorphism. - To evaluate the tolerance of escitalopram and/or paroxetine, on the whole population and according to the 5-HTTLPR polymorphism. - To determine the clinical factors associated with a nonresponse after 12 and 24 weeks of treatment. - To estimate the association between the consciousness of the disorders (insight of the OCD) and the treatment answer after 12 and 24 weeks | — |
Countries
France
Outcome results
None listed