PER-001-95
Completed
未知
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.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ELI LILLY INTERAMERICA INC.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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