None listed
Conditions
Interventions
GROUP Type of group
All patients will take 1 capsule of fluoxetine 90 mg weekly for 24 weeks. The first dose will be administered during visit 3 in the presence of the researcher. On that visit you will be given a capsule for the following week and the time of day that the doctor considers will be more suitable for the patient to take their medication and tolerate it well.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: [1] Male or female outpatients between 18 to 65 years of age. [2] Having had a successful response to treatment with Fluoxetine 20 mg / day for at least 8 weeks. The indication for therapy with fluoxetine must have been for the treatment of major depressive episode of moderate intensity, according to the DSM-IV criteria. [3] HAMD17 score <or equal to 9 (in Visits 1 and 2) [4] CGI-S score <or equal to 2 (in Visits 1 and 2)
Exclusion criteria
Exclusion criteria: 1] Any anxiety disorder as current or recent primary diagnosis (within the last 6 months) of illness or cause of disability, except simple phobias. [2] A history of prior schizophrenia or other psychotic disorder. [3] Any other disorder of the current or recent primary Axis (within the last year) of disease or that is a cause of disability other than major depressive episode. [4] Presence of a disorder in the Axis n which, in the opinion of the researcher, would interfere with the adequacy with the study protocol. [5] Absence of response in the current episode for 2 or more antidepressant treatments at appropriate doses and times, or suspicion of previous resistance to antidepressants. [6] Absence of response to adequate treatment of fluoxetine antidepressant therapy for major depression. [7] Suicide risk which, in the opinion of the investigator, puts the patient at risk. [8] Medical illness, including any cardiovascular, hepatic, renal, respiratory, hematological, endocrinological or neurological disease or clinically significant laboratory abnormality, which, in the opinion of the investigator or clinical physician of Lilly, would prohibit the patient´s safe participation. Any medical illness that is anticipated requires hospitalization for treatment (eg, a respiratory illness with severe worsening depending on the season) or invasive diagnostic procedure (eg, angiography) at any point during the study [9] Any form of active psychotherapy during the study that is not psychoeducation and usual clinical care. [10] Frequent or severe allergic reactions with multiple medications, severe adverse drug reactions or known allergic reaction to fluoxetine.
Countries
Colombia, Ecuador, Paraguar, Peru, Venezuela
Outcome results
None listed