UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057824 |
|---|---|
| Receipt number | R000066069 |
| Scientific Title | N-of-1 evaluation of the effectiveness and safety of a homeopathy protocol for the treatment of major depression in older adults: N1HomEDep Studies |
| Date of disclosure of the study information | 2025/05/10 |
| Last modified on | 2025/05/10 04:29:07 |
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Basic information
Public title
N-of-1 evaluation of the effectiveness and safety of a homeopathy protocol for the treatment of major depression in older adults
Acronym
N1HomEDep
Scientific Title
N-of-1 evaluation of the effectiveness and safety of a homeopathy protocol for the treatment of major depression in older adults: N1HomEDep Studies
Scientific Title:Acronym
N1HomEDep
Region
| South America |
Condition
Condition
Major Depressive Disorder in older adults.
Classification by specialty
| Medicine in general | Gastroenterology | Geriatrics |
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of a homeopathy protocol for the treatment of major depressive disorder in older adults.
Basic objectives2
Others
Basic objectives -Others
To evaluate the clinical and physiological effects of individualized homeopathic treatment and he physicochemical properties of the homeopathic medications.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Progression of the depressive symptoms, self-assessed by the participant using the Beck Depression Inventory - Second Edition (BDI-II) at weeks 0-2-4-8-12-16-18-20-24-26-28 and analyzed throughout the study concerning homeopathy and placebo partitions.
Key secondary outcomes
Secondary Measures: Clinical Global Impression scale (CGI); mental and physical health scores from the 12-Item Short-Form Health Survey (SF-12); participant preference for treatment A or B; clinical worsening, defined as an increase of five or more points (minimal clinically important difference on the BDI-II scale) in the depression score, persistent for at least four weeks; heart rate variability; Adverse Events at weeks 0-2-4-8-12-16-18-20-24-26-28 and analyzed throughout the study concerning homeopathy and placebo partitions. Heart rate variability will be assessed at the beginning of the open-label phase and at the beginning and end of each treatment block.
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Homeopathic medication (verum) individualized according to the protocol of the 6th edition of the Organon by Samuel Hahnemann and administered in ascending fifty-millesimal potencies (LM2-LM3-LM4...), dispensed in solution, prepared with 1 globule of the medication diluted in 20 ml of 30% alcohol. The participant should drop one drop onto the tongue once a day, after having applied 10 succussions to the vial. The dosage may be adjusted according to clinical criteria. Placebo: solution containing 20 ml of 30% alcohol, administered in the same dosage as the verum medication.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Women and men aged 60 years or older, with a diagnosis of Major Depressive Episode confirmed by a psychiatrist, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - 5th edition, and who have presented a therapeutic response (>= 50% reduction in the baseline depression score, maintained for at least four weeks) during a previous open-label homeopathic treatment, with or without concomitant use of psychotropic medications. The ability to understand, agree to, and provide written consent to the terms and procedures of the study will be required for inclusion.
Key exclusion criteria
Depression secondary to a medical condition, suicidal behavior, defined as attempted suicide within 24 months, and psychotic symptoms.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ubiratan |
| Middle name | Cardinalli |
| Last name | Adler |
Organization
Sao Carlos Federal University - Sao Paulo - Brazil
Division name
Medicine Department
Zip code
13565905
Address
Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
TEL
+55163351-8340
ubiratanadler@ufscar.br
Public contact
Name of contact person
| 1st name | Ubiratan |
| Middle name | Cardinalli |
| Last name | Adler |
Organization
Sao Carlos Federal University
Division name
Medicine Department
Zip code
13565905
Address
Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
TEL
+55163351-8340
Homepage URL
https://www.dmed.ufscar.br/
ubiratanadler@ufscar.br
Sponsor or person
Institute
Department of Clinical Medicine, Faculty of Medicine/Federal University of Ceara, Fortaleza (Ceara), Brazil
Institute
Department
Personal name
Prof. Dr. Lia Lira Olivier Sanders
Funding Source
Organization
National Council for Scientific and Technological Development (CNPq, process number 444634/2023-1, 309011/2022-1 and 175216/2023-1)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Brazilian
Other related organizations
Co-sponsor
Sao Carlos Federal University - Sao Carlos - Sao Paulo - Brazil
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Walter Cantidio University Hospital of the Federal University of Ceara
Address
Rua Coronel Nunes de Melo,1142 - CEP 60.430-270 - Fortaleza - Ceara - Brazil
Tel
+55853366-8589
cephuwc@huwc.ufc.br
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Mental Health Unit of the University Hospital Walter Cantidio of the Ceara Federal University, Fortaleza, Ceara, Brazil.
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 10 | Day |
Last modified on
| 2025 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066069
