• 50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks [ Time Frame: 8 weeks ]
  

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

Rellidep is an extract of fertilized hen's eggs which is relatively inexpensive and free of adverse metabolic or psychological side-effects. It has been shown in some clinical situations to improve a number of mood parameters. Its only known contraindication is an allergy to hens' eggs.

A number of published and anecdotal clinical studies in humans have used fertilized chicken egg extract for different indications. This extract was trialed as an anti-cancer agent by Davidson who injected it subcutaneously into mice and noted a reduction in tumour size. In his publications he also cited response in human subjects. Not only did Davidson note reduction in tumour size, his patients suffered no ill effects from the treatment.

In clinical trials of FEE to stimulate sexual interest the majority of subjects reported increased well being, enhanced sexual responsiveness, improvement in self-esteem and an increased level of happiness.

If sexual dysfunction is improved there could naturally follow an improvement in overall mood and lifting of depression. The reverse might be equally as persuasive an argument or more so, i.e. if the mood is enhanced by the lifting of depressive or negative feelings of sadness, anxiety or dysthymia, there then could follow enhanced sexual responsiveness. Rellidep therefore, has the capacity to improve mood. Testing this in controlled clinical trials is the logical next step.

In an unpublished European pilot study 18 subjects diagnosed with depression were treated with approximately 1700 mg daily of an extract of fertilized chicken eggs to assess its antidepressant activity.

The study ran for 8 weeks with depression parameters measured at baseline, 3 weeks and 8 weeks. The scales used were MADRS (score range 0-6) and a variation of the PTSF10 scale (score range 0-7).

At baseline the mean MADRS score was 20. By week 3 the score had fallen to 12 (a 43% reduction) and by week 8, there was a further fall to 9 (a 55% reduction). The 3 most responsive subjects, all of whom were deemed to be suicidal, had a mean score of 34 at the outset which fell to 7 at 8 weeks, representing an 80% reduction in their symptomatology.

The changes in the modified PTSF scale (PTSF10 + 5 additional questions) were inconsistent but there appeared to be a general downward trend.

Study Objectives

Primary Objectives: To evaluate the safety and efficacy of Rellidep 2000 mg/day in the management of Major Depressive Disorder in a psychiatric clinic setting. Secondary Objectives: To evaluate the effect of Rellidep on anxiety and quality of life in the management of Major Depressive Disorder.

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 conditition (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).
• Allergies to eggs.