The investigators hypothesize that Rellidep will be effective in improving the symptoms of major depression. The available evidence strongly suggests that Rellidep contains a mood altering ingredient or ingredients. This open-label, non-randomized study sets out to validate its potential antidepressant activity.The study will include secondary aims of evaluating the effect of Rellidep on reducing symptoms of anxiety, a common symptom associated symptom of depression and improving quality of life. About twenty-five patients with major depressive disorder will be assigned to open-label Rellidep (2000 mg/day) for a period of 8 weeks. All patients will be assessed by various measures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
2000 mg P.O. daily for 8 weeks
Mount Sinai Hospital
Toronto, Ontario, Canada
50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks
Time frame: 8 weeks
Clinical Global Impression-Severity and Improvement
Time frame: 8 weeks
Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks
Time frame: 8 weeks
Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks
Time frame: 8 weeks
Beck Depression Inventory Scale (BDI) a t 8 weeks
Time frame: 8 weeks
Hamilton rating scale for Anxiety (HAM-A)at 8 weeks
Time frame: 8 weeks
UKU
Time frame: 8 weeks
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