DepressionPhase 2/3NCT00446719
Safety and Antidepressant Effects of Rellidep in Major Depressive Disorder
A Phase 2/3 study testing Rellidep in people with Depression, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- Rellidep
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Dec 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (BI= Biological Isolate) in Major Depressive Disorder
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
- Being tested
- Rellidep
- Keywords
- major depression, antidepressant, quality of life, anxiety
- Medical subject headings
- Depression, Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RellidepDrug
2000 mg P.O. daily for 8 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks
Measured: 8 weeks
Secondary outcomes (6)
Clinical Global Impression-Severity and Improvement
Measured: 8 weeks
Montgomery Asberg Depression Rating Scale (MADRS) at 8 weeks
Measured: 8 weeks
Medical Outcomes Study Short-Form 36 (SF-36)at 8 weeks
Measured: 8 weeks
Beck Depression Inventory Scale (BDI) a t 8 weeks
Measured: 8 weeks
Hamilton rating scale for Anxiety (HAM-A)at 8 weeks
Measured: 8 weeks
UKU
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Investigators
- Joel Sadavoy M.D., Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446719
- Sponsor's protocol ID
- MSH 06-0307-A
- Status last verified
- Jan 2011
- First submitted
- 9 Mar 2007
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study Evaluating the Safety and Antidepressant Effects of Rellidep (BI= Biological Isolate) in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00446719
- Acronym / sponsor ID
- MSH 06-0307-A
- Conditions
- Depression
- Keywords
- major depression, antidepressant, quality of life, anxiety
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rellidep2000 mg P.O. daily for 8 weeks | Drug | – |
Primary outcome
50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks
Time frame: 8 weeks
6 secondary outcomes
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
UKU
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Sadavoy M.D. principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rellidep in people with Depression, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% improvement on Hamilton Depression Rating Scale-17 at 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2011.