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Sponsored by: |
Mount Sinai Hospital, Canada |
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Information provided by: | Mount Sinai Hospital, Canada |
ClinicalTrials.gov 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 |
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Depression |
Drug: fertilized egg extract (Rellidep) |
Phase II Phase III |
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 |
Estimated Enrollment: | 25 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2007 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joel Sadavoy, M.D. | 416 586 5262 | jsadavoy@mtsinai.on.ca |
Contact: Jerald Bain, M.D. | 416 586 4800 ext 4436 | jbain@mtsinai.on.ca |
Canada, Ontario | |
Mount Sinai Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 1X5 | |
Principal Investigator: Joel Sadavoy, M.D. |
Principal Investigator: | Joel Sadavoy M.D. | MOUNT SINAI HOSPITAL |
Study ID Numbers: | MSH 06-0307-A |
Study First Received: | March 9, 2007 |
Last Updated: | August 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00446719 |
Health Authority: | Canada: Ethics Review Committee |
major depression antidepressant quality of life anxiety |
Depression Mental Disorders Mood Disorders Quality of Life |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |