UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050075 |
|---|---|
| Receipt number | R000057034 |
| Scientific Title | Homeopathy for Major Depressive Disorder: protocol for N-of-1 studies |
| Date of disclosure of the study information | 2023/01/18 |
| Last modified on | 2024/01/25 01:30:46 |
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Basic information
Public title
Homeopathy for Major Depressive Disorder
Acronym
HOMDD-1
Scientific Title
Homeopathy for Major Depressive Disorder: protocol for N-of-1 studies
Scientific Title:Acronym
HOMDD-1
Region
| South America |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Medicine in general | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness and safety of the homeopathy method of the sixth edition of the Organon in treating individual cases of major depression.
Basic objectives2
Others
Basic objectives -Others
Using N-of-1 studies to substantiate the clinical decision about continuing or not with the homoeopathic treatment in every participant.
Aggregating results from a series of N-of-1 studies to arrive at broader and generalizing conclusions about the effectiveness of the homeopathy protocol of the sixth edition of the Organon in treating depression.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Score of the Beck-II Depression Inventory (BDI-II), self-evaluated by the participant in weeks 0-2-4-8-12-16-20-24-28 and analyzed throughout the study in homeopathy and placebo partitions.
Key secondary outcomes
Evaluated in weeks 0-2-4-8-12-16-20-24-28: score of the Clinical Global Impression Scale; mental and physical health scores assessed by the 12-Item Short-Form Health Survey (SF-12); participant's blinded preference for verum or placebo treatment at each block; clinically substantial worsening (characterized by an augmentation in BDI inclusion score greater than or equal to 30%), and Adverse Events.
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
Blocking
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Homeopathy: Individualized homeopathic medication following the method of the sixth edition of the Organon
Placebo: Indistinguishable solution containing 20 ml of 30% alcohol, administered in the same posology 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Women and men at age over 18 years, with a diagnosis of a Major Depressive Episode given by a psychiatrist, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), presenting a therapeutic response (reduction greater than or equal to 50 percent of the baseline depression score, kept for at least four weeks) during a prior open homeopathic treatment, with or without concomitant use of psychotropic drugs. The capacity to understand and agree and a written consent form with the terms and procedures of the study will be necessary for inclusion.
Key exclusion criteria
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 Carlos, SP, Brazil
Division name
Department of Medicine
Zip code
13565-905
Address
Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil
TEL
00551633518340
ubiratanadler@ufscar.br
Public contact
Name of contact person
| 1st name | Lia |
| Middle name | Lira Olivier |
| Last name | Sanders |
Organization
Federal University of Ceara
Division name
Department of Medicine
Zip code
60430-140
Address
Rua Prof. Costa Mendes, 1608, Bloco Didatico 4 andar. Fortaleza, CE, Brazil
TEL
00558533668004
Homepage URL
lia_sanders@hotmail.com
Sponsor or person
Institute
Federal University of Ceara. Hospital Universitario Walter Cantidio
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Brazilian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Hospital Universitario Walter Cantidio
Address
Rua Coronel Nunes de Melo,1142 Fortaleza CE 60.430-2760.430-27
Tel
00558533668589
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
May 16, 2023: Study Protocol has been published: https://pubmed.ncbi.nlm.nih.gov/37231828/.
August 8, 2023: Two N-of-1 trials are currently being conducted.
October 17, 2023: Four N-of-1 trials are currently being conducted.
January 24, 2024: baseline and follow-up data of Participant 001 has been registered at REDCAp (https://www.redcap.cabsin.org.br/). Participant 001 has completed the study, and the results are being analyzed.
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057034
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
