Elderly depressed patients, MDD, DSM IV-TR, single episode or recurrent
Conditions
Interventions
Trade Name: Sipralexa
Pharmaceutical Form: Tablet
Sponsors
Universitair Psychiatrisch Centrum KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • In- and outpatients • Depressed patients, MDD, DSM IV-TR, single episode or recurrent • GDS > 11 • Elderly patients > 65 years • MMSE score > 24 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: • The patient suffers from any condition (e.g. Parkinson's disease, dementia, psychotic disorders, mental retardation, substance- or alcohol abuse, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR) that might effect cognitive or fine motor processes or compromise the study in another way. • The patient presents a personality disorder that might compromise the study. • The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance. (If there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient’s participation in the study, the patient may be included). • The patient uses the following disallowed recent or concomitant medication within the specified time periods: - any antidepressant within the last week (5 weeks for fluoxetine, 2 weeks for fluvoxamine) prior to baseline. - monoamine oxidase inhibitors (MAOIs) or reversible monoamine oxidase A inhibitors (RIMAs) within 2 weeks prior to baseline. - any drug used for augmentation of antidepressant action within the last week prior to baseline. - any anxiolytics (including benzodiazepines) within the last week prior to baseline. - any hypnotics within the last week prior to baseline, except zolpidem, zopiclone or zaleplon which can be prescribed episodically for insomnia. - oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline. - serotonergic medicinal products (for example, triptans, tryptophan, tramadol) within the last week prior to baseline. - Lithium or valproate or other mood stabilizers within 2 weeks prior to baseline. - Electroconvulsive therapy within 6 months prior to baseline. - Herbal remedies, which are psychoactive (for example, St. Johns Wort, kava kava, valerian, ginkgo biloba) within the last week prior to baseline. - Any other drug with potential psychotropic effects within the last week prior to baseline. - Any anticonvulsant drug within the last 2 weeks prior to baseline. - Anticoagulants and/or medicinal products known to affect platelet function within the last 2 weeks prior to baseline. - Potent inhibitors of CYP2C19 (for example, omeprazole) within the last 2 weeks prior to baseline. - Cimetidine within the last week prior to baseline. - Medicinal products that are predominantly metabolized by CYP2D6 if they have a narrow therapeutic index (for example, flecainide and propafenone) within the last 2 weeks prior to baseline. - Any antihistaminics prior to baseline - Any anitcholinergics prior to baseline. • The patient has demonstrated a lack of response to previous treatment with citalopram or escitalopram (including current episode). • The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or one of the ingredients. • The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm a beneficial effect of escitalopram on depressive symptoms and on cognition and motor retardation in elderly depressed patients.;Secondary Objective: To assess the timeframe in which different aspects of the depressive disease get better; cognitive impairment could resolve faster compared to the core depressive symptoms.;Primary end point(s): Changes in GDS (Geriatric Depression Scale) and cognitive and psychomotor functioning during a 12 week Sipralexa treatment. | — |
Countries
Belgium
Outcome results
None listed