None listed
Conditions
Interventions
1 comparative placebo tablet will be administered once a day before bedtime for 8 weeks.
Group name:20 mg Paroxetine hydrochloride Type of group
Paroxetine hydrochloride in 20 mg capsules will be administered together with two capsules with placebo in bottles A, B and C.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: *Male or female patients who need treatment with antidepressant medications. *Over 18 years of age.
Exclusion criteria
Exclusion criteria: * Women who are pregnant or breastfeeding or intend to get pregnant in the next 12 months * Contraindication or history of hypersensitivity to paroxetine hydrochloride.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The Hamilton Rating Scale for 21-Point Depression (HAMD), the Hamilton Rating Scale for 14-Point Anxiety (HAMA), the Montgomery and Asberg Depression Rating Scale (ECDMA), the Global Impression Scale Clinics - Severity of the Disease (IGC-S) and the Scale of Clinical Global Impressions - Improvement (IGC-M). Measure:Efficacy of MK-0869 (160 mg, 80 mg), compared to placebo, to improve depression, which is measured by changing the baseline on the first 17 points of the total score of the Hamilton Depression Scale of 21 points (HAMD-17). Timepoints:2 week ; Outcome name:At the Pre-study visit, the psychiatrist will obtain a psychiatric history. A psychiatrist or other doctor will obtain a medical history in the pre-study visit and perform a physical examination in the Pre-study visit, at the end of Week 8, and in accordance with the Study Flow Chart. Laboratory evaluations (hematology, chemistry, urinalysis) and electrocardiograms (ECGs) will also be obtained according to the Study Flowchart. In the Pre-study visit, at the end of Week 8, a pregnancy test (p-hCG) will be performed, and then every 2 months during the extension phase in women of childbearing age. Vital signs and weight will be recorded on all visits. Measure:Determine the safety and tolerability of MK-0869 (160 mg, 80 mg). Timepoints:week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical Global Impressions Scale - Improvement (IGC-M). Measure:To determine the efficacy of MK-0869 (160 mg, 80 mg) compared to placebo, to improve depression, which is measured by the actual GCI-M score. Timepoints:week 8 | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed