A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects with Major Depressive Disorder
- Conditions
- Major Depressive Disorder (MDD)
- Registration Number
- EUCTR2004-004984-32-SE
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 348
Subjects must have the ability to comprehend the key components of the consent form.
Male or female outpatients aged 18-64, inclusive.
3A primary diagnosis of MDE associated with MDD, single episode or recurrent, according to DSM-IV-TR (296.2 or296.3), diagnosed through a comprehensive psychiatric evaluation [in conjunction with the Mini International Neuropsychiatric Interview (MINI), Clinician Rated Version 5.0], as assessed by a physician with adequate training in psychiatry (e.g. Board Certified psychiatrist).
Subjects must, in the investigator’s opinion based on the subject’s history, have met DSM-IV-TR criteria for their current MDE for at least 8 weeks prior to the Screening Visit.
Subjects with a Carroll Depression Scale-Revised (CDS-R) self-assessment total score of less than or equal to 24 at the Screen Visit and Baseline Visit.
Subjects must have a CGI- Severity of Illness score = 4 at the Baseline Visit.
Subjects with a history of peptic ulcer disease (PUD) with a known etiology must provide documentation by a gastroenterologist of the etiology of the PUD and that effective treatment was provided with full eradication of ulcers and symptoms. For such subjects appropriate steps must also have been taken to minimize reoccurrence risk (i.e. if PUD was nonsteroidal anti-inflammatory drug [NSAID] induced, the subject should no longer be taking NSAID medications; if cause was H. pylori, the subject should have been appropriately treated).
Women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
a)Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses)
b)Child-bearing potential, has a negative serum pregnancy test result at screen and a negative urine dipstick pregnancy test at baseline (prior to study drug administration), and agrees to one of the following:
•Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
•Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm
•Double-barrier method of contraception consisting of spermicide with either condom or diaphragm
•IUD with a documented failure rate of less than 1% per year
•Complete abstinence from intercourse for two weeks before exposure to the investigational product, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of three days, equivalent to five half lives)
c)If subjects indicate they will remain abstinent during the period described above, they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects whose symptoms of the MDE are better accounted for by another diagnosis
Subjects with history of schizophrenia, schizoaffective disorders or bipolar
disorder
Subjects have positive urine test at screening for illegal drug use and/or a history of substance abuse or dependence
Subjects have a blood alcohol level of = 15 mg/dl (0.015%) at the Screening Visit
Subjects are currently receiving regularly scheduled psychotherapy, plan to initiate psychotherapy during the trial or have received regularly scheduled psychotherapy during the 12 weeks prior to the Screening Visit
Subjects have previously failed to respond to adequate courses of pharmacotherapy from two different classes of antidepressants or have failed to respond to an adequate course of paroxetine
Subjects who, in the investigator's judgement, pose a homicidal or serious suicidal
risk, have made a suicide attempt within the 6 months preceding screening or who
have ever been homicidal
Subjects who have received electroconvulsive therapy (ECT) or transcranial
magnetic stimulation (TMS) within the 6 months prior to the Screening Visit.
Subjects with any history of a seizure disorder
Subjects with an unstable medical disorder; or a disorder that would likely interfere
with the action, absorption, distribution, metabolism or excretion of GW679769; or
paroxetine, may pose a safety concern; or interfere with the accurate assessment of
safety or efficacy
Subjects with a history of myocardial infarction within 1 year prior to the
Screening Visit
Subjects have any screening laboratory value outside of the Sponsor-specified ranges at Screening Visit
Subjects have any laboratory abnormality that in the investigator's judgement is
considered to be clinically significant and not resolved by the Baseline Visit
Subjects who are not euthyroid based on lab results at the Screening Visit.
Subjects maintained on thyroid medication must be euthyroid for a period of at least 6 months prior to the Screening Visit
Subjects have any screening electrocardiography (ECG) parameter outside of the
Sponsor-specified ranges
Subjects have any ECG finding that in the investigator's judgement is considered to
be clinically significant and not resolved by the Baseline Visit
Subjects with active PUD and/or history of PUD of an unknown etiology
Subjects with a screening serology test that is positive for H. pylori
Subjects who will likely require the use the following medications:
- NSAIDs (unless administered concomitantly with an anti-secretory, i.e. proton-pump inhibitor or histamine-2 receptor antagonist and administered in the absence of aspirin therapy); or
- concomitant use of aspirin and COX2 inhibitors.
Subjects found to have stool positive for occult blood
Subjects with known or suspected iron deficiency
Women who have a positive serum HCG pregnancy test at the Screening Visit, a
positive urine dipstick test at the Baseline (Randomization) Visit, or who are
lactating or planning to become pregnant within the 4 months following the Screen
Visit
Subjects who have taken other psychoactive drugs within two weeks prior to the
Baseline Visit or at any time during the Screening period:
• all antidepressants including SSRI's
• Monoamine Oxidase Inhibitors (MAOIs), benzodiazepines, other psychoactive
medications (including psychoactive herbal treatments, e.g., St. John's Wort,
SAM-e)
• Hypnotics, and all other sedatives (including sedating antihistamines if used for
their sedating and/or hypnotic
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the antidepressant efficacy of GW679769 (80 to 120 mg/day) versus placebo;Secondary Objective: To assess the safety and tolerability of GW679769<br><br>To provide data to analyse the relationship between response and dose/plasma concentration of GW679769<br>;Primary end point(s): Change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
- Secondary Outcome Measures
Name Time Method