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Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446719
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : January 5, 2011
Information provided by:
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Rellidep Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Intervention Details:
  • Drug: Rellidep
    2000 mg P.O. daily for 8 weeks

Primary Outcome Measures :
  1. 50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression-Severity and Improvement [ Time Frame: 8 weeks ]
  2. Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks [ Time Frame: 8 weeks ]
  3. Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks [ Time Frame: 8 weeks ]
  4. Beck Depression Inventory Scale (BDI) a t 8 weeks [ Time Frame: 8 weeks ]
  5. Hamilton rating scale for Anxiety (HAM-A)at 8 weeks [ Time Frame: 8 weeks ]
  6. UKU [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446719

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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
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Principal Investigator: Joel Sadavoy M.D. MOUNT SINAI HOSPITAL

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Responsible Party: Joel Sadavoy MD. Head community psychiatry and geriatric psychiatry programs, 600 university Ave Toronto M5G 1X5 Identifier: NCT00446719     History of Changes
Other Study ID Numbers: MSH 06-0307-A
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: January 2011
Keywords provided by Mount Sinai Hospital, Canada:
major depression
quality of life
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs