Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

Not Applicable

• Conditions: -F33; F33

• Registration Number: PER-053-05
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-02
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects must have the ability to understand the key components of the consent form.
2. Outpatient, male or female patients aged 18-64.
3. Primary diagnosis of EDM associated with TDM, single or recurrent episode.
4. The subjects must, in the opinion of the researcher based on the subject´s history, have met the DSM-IV-TR criteria for their current EDM for at least 8 weeks before the Screening Visit.
5. Subjects with a total score on self-assessment with the Carroll Depression Scale - Revised (CDS-R) of> 24 at the Screening Visit and at the Baseline Visit.
6. Subjects must have a CGI-Severity of disease score> 4 at the baseline visit.
7. Subjects with a history of peptic ulcer disease (PCP) with a known etiology should provide documentation from a gastroenterologist on the etiology of the EUP and that effective treatment with total eradication of ulcers and symptoms was provided.
8. Women of reproductive age should commit to the consistent and correct use of an acceptable method of birth control.

Exclusion Criteria

1. Subjects whose EDM symptoms are best explained with another diagnosis.
2. Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
3. Subjects that have a positive test for illegal substance use and / or a history of substance abuse or dependence.
4. Subjects who currently receive regularly scheduled psychotherapy, plan to initiate psychotherapy during the test or have received regularly scheduled psychotherapy during the 12-week period prior to the Screening Visit.
5. Subjects who previously did not respond to adequate courses of pharmacotherapy of two different classes of antidepressants or who did not respond to an adequate course of paroxetine.
6. Subjects that in the opinion of the investigator, have serious homicidal or suicidal risk, have attempted suicide within 6 months before screening or have had a homicidal tendency at some time.
7. Subjects who received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 6 months before the Screening Visit.
8. Subjects with a history of seizure disorders.
9. Subjects with unstable medical disorder; or a disorder that is likely to interfere with the action, absorption, distribution, metabolism, or excretion of GW679769, or paroxetine.
10. Subjects with a history of myocardial infarction within one year before the Screening Visit.
11. Subjects with a laboratory value for screening outside the specified ranges.
12. Subjects with laboratory abnormalities considered by the investigator to be clinically significant.
13. Subjects that are not euthyroid.
14. Subjects with a parameter in electrocardiography (ECG) screening outside the specified ranges.
15. Subjects with an ECG finding that the researcher deems clinically significant.
16. Subjects with active EUP and / or EUP history of unknown etiology.
17. Subjects that probably require the use of the following medications: NSAIDs, COX2 inhibitors.
18. Subjects that have been discovered have positive feces for occult blood.
19. Subjects known or suspected iron deficiency.
20. Women with a positive serum HCG pregnancy test.
21. Subjects who have taken other psychoactive drugs in the space of two weeks before.
22. Subjects who have taken other drugs metabolised by the cytochrome P450 3A4 route with a narrow therapeutic index within 2 weeks before the baseline visit.
23. Subjects who have taken other drugs that are inhibitory
potent or moderate or inducers of the cytochrome P450 3A4 route within 2 weeks before the baseline visit.
24. Subjects with hypersensitivity or intolerance to NK1 antagonists or SSRIs.
25. Subjects who participated in a clinical trial that involved GW679769.
26. Subjects currently participating in another clinical trial in which the subject is or will be exposed to a drug or device under investigation.
27. Subjects who do not have contact with an adult on a daily basis.
28. Subjects taking triptan drugs, the antibiotic linezolid or tryptophan.
29. Subjects with a history of myopathy or rhabdomyolysis.
30. Subjects who regularly participate in strenuous exercises.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Hamilton Rating Scale for Depression (HAM-D and HAM-A). Carroli Scale for Depression Revised (CDS-R).<br><br>Measure:Severity of depressive symptoms.<br>Timepoints:AM-D and HAM-A: Weeks 1, 2,3, 4, 5, 6, 7, 8 and follow-up visit at 14 days.<br>Carroli scale: Week 1 and at the end of the treatment.<br>