Depression Clinical Trial
Official title:
An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (BI= Biological Isolate) in Major Depressive Disorder
Verified date | January 2011 |
Source | Mount Sinai Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Signed written informed consent obtained. - Males/Females 20-65 years of age who require a new or a new change in their medication treatment for diagnosed major depression. - A clinical diagnosis fulfilling DSM-IVTR criteria for Major Depressive Disorder, single episode or recurrent. - 17-Item Hamilton Depression Rating Scale (HAMD 17-item) total score at baseline of 18 or higher Exclusion Criteria: - Clinical diagnosis of depression other than DSM-IVTR Major Depressive Disorder (single episode/recurrent, e.g. chronic depression and/or refractory depression are excluded). - Judged to be at significant risk for suicide or having a history suggesting significant current potential for self harm. - Antidepressant medication (other than the index antidepressant). - Women who are pregnant or breast-feeding or intending to become pregnant in the next 12 months. - Clinically significant organ system diseases, e.g. cardiovascular, hepatic, renal, endocrine, gastrointestinal, metabolic, or other systemic diseases. - Course of electroconvulsive therapy (ECT) during the observational period. - Suffer from a major neurological condition (i.e., Parkinson's disease, Huntington's disease), cerebrovascular disease (i.e., stroke), metabolic conditions (i.e., Vitamin B12 deficiency), autoimmune conditions (i.e., systematic lupus erythematosus), viral or other infections (i.e., hepatitis, mononucleosis, human immunodeficiency), and cancer. - Current diagnosis of Schizophrenia or other psychotic disorders (including Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, brief psychotic disorders, psychotic disorder due to general medical condition, substance induced psychotic, psychotic disorder not otherwise specified) as defined in the DSM-IV. - (Sub) clinical hypo/hyper thyroidism (e.g. elevated TSH). |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Mount Sinai Hospital, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks | 8 weeks | Yes | |
Secondary | Clinical Global Impression-Severity and Improvement | 8 weeks | No | |
Secondary | Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks | 8 weeks | Yes | |
Secondary | Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks | 8 weeks | Yes | |
Secondary | Beck Depression Inventory Scale (BDI) a t 8 weeks | 8 weeks | No | |
Secondary | Hamilton rating scale for Anxiety (HAM-A)at 8 weeks | 8 weeks | No | |
Secondary | UKU | 8 weeks | Yes |
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