EUCTR2006-002411-27-BE
Active, not recruiting
Not Applicable
Evaluation of the effect of escitalopram on cognitive and fine motor function in depressed elderly patients.
niversitair Psychiatrisch Centrum KU Leuven0 sites40 target enrollmentSeptember 27, 2006
DrugsSipralexa
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Psychiatrisch Centrum KU Leuven
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In\- and outpatients
- •Depressed patients, MDD, DSM IV\-TR, single episode or recurrent
- •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
- •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.
Outcomes
Primary Outcomes
Not specified
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