A randomised, double-blind, placebo-controlled study to explore the antidepressant properties of the P38a kinase inhibitor GW856553X 15mg compared to placebo in subjects with Major Depressive Disorder exhibiting symptoms of loss of energy and interest, and psychomotor retardation, for a six week treatment period.
- Conditions
- Major Depressive DisorderMedDRA version: 8.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS
- Registration Number
- EUCTR2006-005578-39-EE
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
A full list of Inclusion Criteria for MDD subjects can be found in the protocol. The criteria below are those that have been amended.
9. Subject currently meets the diagnosis for MDD (without psychotic features), recurrent, as defined in the DSM-IV-TR, diagnosed with a comprehensive psychiatric evaluation incorporating the MINI, as assessed* by a physician with adequate training in psychiatry. *Assessment by a physician with adequate training in psychiatry must include a face-to-face evaluation of the subject, but may be aided by subject evaluation conducted by a healthcare professional with a clinically relevant qualification (e.g., psychiatric nurse or psychologist) and a minimum of two years of documented experience assessing subjects with MDD and appropriate training in IDS-C scoring
10. Subject must, in the investigator’s opinion based on clinical history, have met DSM IV-TR criteria for their current Major Depressive Episode for at least 4 weeks but for no greater than 24 months.
11. Subject must have had at least one previous major depressive episode with a diagnosis of MDD in his/her history, and had a successful pharmacological treatment of that episode, and is currently experiencing a recurrence of MDD presently un-medicated or inappropriately treated.
12. Subjects must exhibit moderate to severe levels of depression as defined by:
• a minimum score of 17 on the QIDS-SR16 and a minimum score of 1 for the Items representing mood depression, interest, energy and psychomotor retardation when measured at the Screening visit (Week -1) and the Randomisation visit (Week 0).
• a minimum total score of 36 on the IDS-C when measured at the Screening visit (Week -1) and at the Randomisation visit (Week 0) with a minimum score of 1 on Items representing mood depression, interest, energy, and psychomotor retardation.
A full list of Inclusion Criteria for healthy subjects can be found in the protocol. The criterion below has been added.
2. Subject has total score <=10 on the QIDS SR 16 IVRS at the Screening (week -1) and additional visit (Week 0)
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)
F.1.3.1 Number of subjects for this age range
A full list of Exclusion Criteria for MDD subjects can be found in the protocol. The criteria below are those that have been amended.
4. The subject has a history of elevated liver function tests on more than one occasion (ALT, AST, and total bilirubin > 2 x ULN or ALP > 3 x ULN) in the past 7 months.
5. The subject has significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions that, in the opinion of the investigator, place the subject at an unacceptable risk as a participant in this trial.
12. Subject has a positive urine test at the Screening or Randomisation (Week 0) visits for illicit drug use with the exception of barbiturates, whose sporadic use as hypnotics has been ascertained, the subject recommended for discontinuation pending verification for barbiturate dependence that will lead to exclusion from the study at any time; a history of DSM IV-TR diagnosis of substance abuse or dependence (other than nicotine) within the past 2 years.
13. Subject’s IDS-C assessment decreases by more than 25% between the Screening (Week -1) and Randomisation (Week 0) visits.
23. Women who have a positive serum Human Chorionic Gonadotropin (HCG) pregnancy test at the Screening visit (Week -1), a positive urine dipstick test at the Second Study Visit (Week 0), or who are lactating or planning to become pregnant within the next 12 weeks following the Screening visit.
25. The subject is currently receiving a chronic biological or pharmacologic anti-inflammatory therapy (includes both non-steroidal anti-inflammatory agents and corticosteroids); interferon therapy at any dose or did receive them within 6 months prior randomisation; vaccinations performed within 1 month or less prior to the Screening Visit.
26. Subjects who have taken other psychoactive drugs unles otherwise stated in the protocol between the Screening and the Randomisation visit (approximately 1-2 weeks).
A full list of Exclusion Criteria for healthy subjects can be found in the protocol. The criteria below are those that have been amended.
13. Subject has a systolic blood pressure (SBP) > 160mmHg or a diastolic blood pressure (DBP) > 95mmHg at the Screening (Week –1) or Second Study Visit (Week 0) visit compatible with diagnosis of hypertension.
14. Women who have a positive serum Human Chorionic Gonadotropin (HCG) pregnancy test at the Screening visit (Week -1), a positive urine dipstick test at the Second Study Visit (Week 0), or who are lactating
15. Subjects have any screening electrocardiographic (ECG) parameter outside of the Sponsor-specified ranges; the ECG may be repeated once to see if the parameter returns to within range but any such abnormality must be resolved by the Second Study Visit.
16. The subject is currently receiving a chronic biological or pharmacologic anti-inflammatory therapy (includes both non-steroidal anti-inflammatory agents and corticosteroids); interferon therapy at any dose or did receive them within 6 months prior to the screening visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method