Clinical trial NCT00446719: Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder
Official title: An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (BI= Biological Isolate) in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Keywords: major depression
antidepressant
quality of life
anxiety
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2007-03-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: 50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical Global Impression-Severity and Improvement
timeFrame: 8 weeks
measure: Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks
timeFrame: 8 weeks
measure: Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks
timeFrame: 8 weeks
measure: Beck Depression Inventory Scale (BDI) a t 8 weeks
timeFrame: 8 weeks
measure: Hamilton rating scale for Anxiety (HAM-A)at 8 weeks
timeFrame: 8 weeks
measure: UKU
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Joel Sadavoy M.D.
role: PRINCIPAL_INVESTIGATOR
References: