Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446719
• Other study ID #: MSH 06-0307-A
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 9, 2007
• Last updated: January 4, 2011
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2011
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks		8 weeks	Yes
Secondary	Clinical Global Impression-Severity and Improvement		8 weeks	No
Secondary	Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks		8 weeks	Yes
Secondary	Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks		8 weeks	Yes
Secondary	Beck Depression Inventory Scale (BDI) a t 8 weeks		8 weeks	No
Secondary	Hamilton rating scale for Anxiety (HAM-A)at 8 weeks		8 weeks	No
Secondary	UKU		8 weeks	Yes