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1995.xml
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1995.xml
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<?xml version='1.0' encoding='ISO-8859-1'?>
<trials>
<trial><main><trial_id>PER-001-95</trial_id><utrn/><reg_name>REPEC</reg_name><date_registration>27/10/1995</date_registration><primary_sponsor>ELI LILLY INTERAMERICA INC., </primary_sponsor><public_title>N.A.</public_title><acronym/><scientific_title>Evaluation of the Efficacy and Safety of Fluoxetine Compared with Amitriptyline in the Treatment of Patients with Major Depression Associated with Anxiety in Latin America.</scientific_title><scientific_acronym/><date_enrolment>01/01/1900</date_enrolment><type_enrolment/><target_size>32</target_size><recruitment_status>Finished</recruitment_status><url>http://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=001-95</url><study_type>Interventional</study_type><study_design>A phase 3, randomized, double-blind, double-dummy, parallel-allocation clinical trial to evaluate the efficacy, safety, and tolerability of fluoxetine in comparison to amitriptyline in major depression associated with Anxiety. The study will have a washout period of 11-14 days with placebo followed by an 8-weeks period of active therapy with fluoxetine 20mg/day or amitriptyline 50-250mg/day.</study_design><phase>III</phase><hc_freetext>-F329 Depressive episode, unspecified
</hc_freetext><i_freetext/></main><contacts><contact><type>public</type><firstname/><middlename/><lastname/><address/><city/><country1>Perú</country1><zip/><telephone/><email/><affiliation/></contact><contact><type>Scientific</type><firstname/><middlename/><lastname/><address/><city/><country1>Perú</country1><zip/><telephone/><email/><affiliation/></contact></contacts><countries><country2>Brazil</country2><country2>Colombia</country2><country2>Mexico</country2><country2>Peru</country2><country2>Venezuela</country2></countries><criteria><inclusion_criteria>- Patients of legal age in outpatient treatment. In the case of women of fertile age, they should use an accepted contraceptive method (e.g., intrauterine device, birth control pills for at least one menstrual cycle, implant or diaphragms).
- Provide written informed consent after being informed and read about of the medications and procedures to be used in the study.
- DSM-IV criteria for major depression (except for the duration of the illness, which should be at least 1 month) as measured in the Structured Clinical Interview for Depression (SCID).
- Eighteen or more points in the first 17 items of the HAMD21 score at the time of admission.
- Hamilton´s scale for the Measure of Anxiety (HAMA) of at least 18 at the time of admission.
- Educational level and ability to read, enough to communicate intelligently with the research team
- The patient must agree to keep appointments and cooperate during all tests and examinations required by the protocol.
</inclusion_criteria><agemin/><agemax/><gender/><exclusion_criteria>- Pregnant or lactating women
- Serious risk of suicide
- Serious illnesses such as chronic urinary retention, serious cardiovascular disorders (ischemic heart disease, arrhythmias, conduction defects, hypertension under treatment with guanethidine, reserpine, clonidine or methyldopa, Chagas disease), patients with thyroid disorders or those receiving thyroid medication, organic brain diseases or patients with a history of seizures, acute angle glaucoma, or any other unstabilized disease (renal, hepatic, respiratory, endocrinological, neurological or hematologic) that could require hospitalization within the next 2 months.
- History of severe allergies, multiple adverse reactions to drugs or known allergy to the drugs under study.
- Other psychiatric illnesses, including the following diagnoses of the DSM-IV: organic mental disorders, disorders due to the use of an active substance within the last 6 months, schizophrenic disorders and schizoaffective disorder, paranoid disorders, other psychotic disorders, bipolar disorder, panic, obsessive-compulsive disorder
- Regular use of other psychopharmaceuticals within the preceding 2 weeks including lithium, monoamine oxidase inhibitors (or the potential need to use an MAOI within five weeks of stopping treatment), neuroleptics (depot neuroleptics within 6 weeks) preceding weeks), tryptophan.
- If the patient has taken benzodiazepines more than three days a week for more than four weeks, benzodiazepines should be should gradually reduce before the patient returns for pre-screening purposes.
- Use of other investigational drugs during the past 4 weeks.
- Previous participation in a study with Fluoxetine or amitriptyline.
- History of alcoholism and/or drug abuse in the last 6 months.
- History of failure to treatment with fluoxetine or amitriptyline.
</exclusion_criteria></criteria><health_condition_code><hc_code>F329</hc_code></health_condition_code><health_condition_keyword><hc_keyword>Depressive episode, unspecified</hc_keyword></health_condition_keyword><intervention_code><i_code/></intervention_code><intervention_keyword><i_keyword/></intervention_keyword><primary_outcome/><secondary_outcome/><secondary_sponsor><sponsor_name/></secondary_sponsor><secondary_ids><secondary_id><sec_id>B1-Y-MC-HCIB</sec_id><issuing_authority/></secondary_id><secondary_id><sec_id>N.A.</sec_id><issuing_authority>WHO UTN</issuing_authority></secondary_id><secondary_id><sec_id>N.A.</sec_id><issuing_authority>CLINICAL TRIALS GOV</issuing_authority></secondary_id><secondary_id><sec_id>N.A.</sec_id><issuing_authority>EUDRACT</issuing_authority></secondary_id></secondary_ids><source_support><source_name/></source_support></trial>
</trials>