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Trial registered on ANZCTR


Registration number
ACTRN12609000638235
Ethics application status
Approved
Date submitted
27/07/2009
Date registered
30/07/2009
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of impact and efficacy in a public psychiatric service of a device using micro-current applied at the ear lobe, for major, mild and minor depressive disorders, and generalized anxiety disorders.
Scientific title
Evaluation of impact and efficacy in a public psychiatric service of a device using micro-current applied at the ear lobe, for major, mild and minor depressive disorders, and generalized anxiety disorders.
Secondary ID [1] 940 0
Nil
Universal Trial Number (UTN)
Trial acronym
CN1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
major, mild and minor depressive disorders 237368 0
generalized anxiety disorders 237384 0
Condition category
Condition code
Public Health 239690 239690 0 0
Health service research
Mental Health 239691 239691 0 0
Depression
Mental Health 239692 239692 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Evaluation of impact and efficacy in a public psychiatric service of a device using micro-current applied at the ear lobe, for major, mild and minor depressive disorders, and generalized anxiety disorders. The intervention comprises: A cycle of auricular treatment protocol with Radioelectric Asymetric Conveyer (REAC). The REAC is a Radioelectric medical device. The REAC protocol used, called Neuro Psycho Physical Optimization (ONPF), involves the application of a probe of the REAC on specific points of the auricular pavilion for an activation time of roughly 500 mms. The ONPF protocol is activated in a precise sequence on seven auricular points. The protocol envisages 18 sessions lasting 3.5 seconds each (7X 500 mms) on alternating days, for eight (8) weeks. Assessment, at baseline and immediately at the end of treatment, with Symptomatic Check List (SCL-90R) and Hamilton Test
Intervention code [1] 237020 0
Treatment: Devices
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240460 0
Evaluation of impact and efficacy in a public psychiatric service of a device using micro-current applied at the ear lobe, for major, mild and minor depressive disorders, and generalized anxiety disorders assessed with Symptomatic Check List (SCL-90R) and Hamilton Depression Rating Scale (HDRS)
Timepoint [1] 240460 0
Timepoint 1: at six months after the program start
Timepoint 2: at one year after the program start
Primary outcome [2] 240461 0
Self assessment of personality disorders as measured by SCL 90R.
Timepoint [2] 240461 0
at baseline and at 12, weeks after intervention commencement
Primary outcome [3] 240462 0
Self assessment of depression as measured by HDRS score.
Timepoint [3] 240462 0
at baseline and at 12, weeks after intervention commencement
Secondary outcome [1] 244994 0
No Secondary Outcomes
Timepoint [1] 244994 0
NA

Eligibility
Key inclusion criteria
Subjects without organic diseases, over 18 years old, female and male, with diagnosis of major, mild and minor depressive disorder or generalized anxiety disorders.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects with neurological disease, severe psychiatric disease, psychosis, subjects with antipsychotic medication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
7/01/2008
Actual
7/01/2008
Date of last participant enrolment
Anticipated
Actual
31/12/2010
Date of last data collection
Anticipated
Actual
31/12/2010
Sample size
Target
30
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 1921 0
Italy
State/province [1] 1921 0
Cuneo

Funding & Sponsors
Funding source category [1] 237404 0
Charities/Societies/Foundations
Name [1] 237404 0
Istituto Rinaldi Fontani
Country [1] 237404 0
Italy
Funding source category [2] 237405 0
Hospital
Name [2] 237405 0
Azienda Ospedaliera S.Croce e Carle
Country [2] 237405 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23, 50123 Firenze
Country
Italy
Secondary sponsor category [1] 236901 0
Hospital
Name [1] 236901 0
Azienda Ospedaliera S.Croce e Carle
Address [1] 236901 0
Via Carle. 12100, Frazione Confreria. Cuneo
Country [1] 236901 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239535 0
Comitato Etico Interaziendale (ASO S.Croce e Carle/ASL CN1)
Ethics committee address [1] 239535 0
Ethics committee country [1] 239535 0
Italy
Date submitted for ethics approval [1] 239535 0
Approval date [1] 239535 0
19/10/2007
Ethics approval number [1] 239535 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29971 0
Dr Salvatore Rinaldi
Address 29971 0
Istituto Rinaldi Fontani
Viale Belfiore 43, 50144 Firenze, Italia
Country 29971 0
Italy
Phone 29971 0
+39 055 290307
Fax 29971 0
Email 29971 0
srinaldi@irf.it
Contact person for public queries
Name 13218 0
Elisabetta Olivieri MD
Address 13218 0
Azienda Ospedaliera S.Croce e Carle. Via Carle. 12100, Frazione Confreria. Cuneo
Country 13218 0
Italy
Phone 13218 0
+39 0171 616200 /03
Fax 13218 0
+39 0171 616202
Email 13218 0
Bourget@libero.it
Contact person for scientific queries
Name 4146 0
Elisabetta Olivieri MD
Address 4146 0
Azienda Ospedaliera S.Croce e Carle. Via Carle. 12100, Frazione Confreria. Cuneo
Country 4146 0
Italy
Phone 4146 0
+39 0171 616200 /03
Fax 4146 0
+39 0171 616202
Email 4146 0
Bourget@libero.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.