Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

NCT00446719 | Completed Phase 2

• 1 other identifier: MSH 06-0307-A
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

major depression; antidepressant; quality of life; anxiety

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (6)

• Clinical Global Impression-Severity and Improvement

  8 weeks

• Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks

  8 weeks

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

  8 weeks

• Beck Depression Inventory Scale (BDI) a t 8 weeks

  8 weeks

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

  8 weeks

Interventions

Rellidep DRUG

2000 mg P.O. daily for 8 weeks

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Item Hamilton Depression Rating Scale (HAMD 17-item) total score at baseline of 18 or higher

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Anxiety Disorders

Interventions

rellidep

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Joel Sadavoy M.D.

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 13, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 5, 2011

Record last verified: 2011-01

Locations

CA (1)