Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder - Full Text View

Sponsor:	Mount Sinai Hospital, Canada
Information provided by:	Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:	NCT00446719

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: Rellidep	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (BI= Biological Isolate) in Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Anxiety Depression

U.S. FDA Resources

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:

50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical Global Impression-Severity and Improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Beck Depression Inventory Scale (BDI) a t 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Hamilton rating scale for Anxiety (HAM-A)at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
UKU [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	23
Study Start Date:	August 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

2000 mg P.O. daily for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446719

Locations

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5

Sponsors and Collaborators

Mount Sinai Hospital, Canada

Investigators

Principal Investigator:

Joel Sadavoy M.D.

Mount Sinai Hospital, New York

More Information

No publications provided

Responsible Party:	Joel Sadavoy MD. Head community psychiatry and geriatric psychiatry programs, 600 university Ave Toronto M5G 1X5
ClinicalTrials.gov Identifier:	NCT00446719 History of Changes
Other Study ID Numbers:	MSH 06-0307-A
Study First Received:	March 9, 2007
Last Updated:	January 4, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Mount Sinai Hospital, Canada:

major depression
antidepressant
quality of life
anxiety

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012