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another weird clinical trial

Posted by mike1975 on September 25, 2008, at 21:33:56


I found this:

Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder

This study is currently recruiting participants.
Verified by Mount Sinai Hospital, Canada, August 2007

Sponsored by: Mount Sinai Hospital, Canada

Information provided by: Mount Sinai Hospital, Canada Identifier: NCT00446719

We 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.

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 meaures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.

Condition Intervention Phase
Drug: fertilized egg extract (Rellidep)
Phase II
Phase III

MedlinePlus related topics: Antidepressants Anxiety Depression

U.S. FDA Resources

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title: An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (FEE- Fertilized Egg Extract) in Major Depressive Disorder

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
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 ]

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 ]

Estimated Enrollment: 25
Study Start Date: August 2007
Estimated Study Completion Date: December 2007

Detailed Description:
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.

...I would give it a try. You never know. I just have no idea where to get it.





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