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Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

Primary Purpose

Depression

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Rellidep

About this trial

This is an interventional treatment trial for Depression focused on measuring major depression, antidepressant, quality of life, anxiety

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Mount Sinai Hospital

Outcomes

Primary Outcome Measures

50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks

Secondary Outcome Measures

Clinical Global Impression-Severity and Improvement

Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks

Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks

Beck Depression Inventory Scale (BDI) a t 8 weeks

Hamilton rating scale for Anxiety (HAM-A)at 8 weeks

UKU

Full Information

NCT ID

NCT00446719

First Posted

March 9, 2007

Last Updated

January 4, 2011

Sponsor

Mount Sinai Hospital, Canada

1. Study Identification

Unique Protocol Identification Number

NCT00446719

Brief Title

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

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

major depression, antidepressant, quality of life, anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rellidep

Intervention Description

2000 mg P.O. daily for 8 weeks

Primary Outcome Measure Information:

Title

50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Clinical Global Impression-Severity and Improvement

Time Frame

8 weeks

Title

Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks

Time Frame

8 weeks

Title

Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks

Time Frame

8 weeks

Title

Beck Depression Inventory Scale (BDI) a t 8 weeks

Time Frame

8 weeks

Title

Hamilton rating scale for Anxiety (HAM-A)at 8 weeks

Time Frame

8 weeks

Title

UKU

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Sadavoy M.D.

Organizational Affiliation

MOUNT SINAI HOSPITAL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

12. IPD Sharing Statement

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Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

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