Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

January 4, 2011 updated by: Mount Sinai Hospital, Canada

An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (BI= Biological Isolate) in Major Depressive Disorder

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression-Severity and Improvement
Time Frame: 8 weeks
8 weeks
Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks
Time Frame: 8 weeks
8 weeks
Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks
Time Frame: 8 weeks
8 weeks
Beck Depression Inventory Scale (BDI) a t 8 weeks
Time Frame: 8 weeks
8 weeks
Hamilton rating scale for Anxiety (HAM-A)at 8 weeks
Time Frame: 8 weeks
8 weeks
UKU
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Joel Sadavoy M.D., Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 9, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

January 5, 2011

Last Update Submitted That Met QC Criteria

January 4, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSH 06-0307-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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