None listed
Conditions
Interventions
It is going to be administered twice a day, morning and evening. At weekly intervals (5 to 9 days), two bottles of pills labeled MORNING DOSAGE and NIGHT DOSE will be given to each participant. The capsules of the bottle MORNING DOSAGE will contain placebo, while the capsules of the bottle NIGHT DOSE, will contain amitriptyline 50mg. During the first week, 50mg/day will be administered, in the second week 100mg/day, in the third week 150mg/day, and from the fourth week until the end of the stud
It is going to be administered twice a day, morning and evening. At weekly intervals (5 to 9 days), two bottles of pills labeled MORNING DOSAGE and NIGHT DOSE will be given to each participant. The capsules of the bottle MORNING DOSAGE will contain fluoxetine 20mg, while the capsules of the bottle NIGHT DOSE, will contain placebo. The daily dose of Fluoxetine administered throughout the study will be 20 mg/day.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Incidence rate of all adverse events reported since enrolment of each participant. Measure:Safety and tolerability of Fluoxetine compared to Amitriptyline Timepoints:During the whole participation in the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Variacion de los puntajes de severidad de depresion y ansiedad (HAMD21, CGI-S, CGI-I, PGI, HAMA, y puntuaciones de Raskin-Covi) en cada visita del periodo de tratamiento activo. Measure:Efficacy of Fluoxetine compared to Amitriptyline Timepoints:Last day of washout period (final indicator) and each visit during the active Treatment Period (week 3,4, 6, 8 and 10). ; Outcome name:Those used in the primary endpoint and first secondary endpoint according to country, sex and age. Measure:Efficiency and safety by subgroups Timepoints:As referred in the primary endpoint and first secondary endpoint. | — |
Countries
Brazil, Colombia, Mexico, Peru, Venezuela
Outcome results
None listed