Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000570684
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
28/05/2014
Date last updated
12/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of citalopram versus a placebo on central auditory processing in the elderly.
Scientific title
The effect of citalopram versus a placebo on central auditory processing in the elderly.
Secondary ID [1] 284590 0
none
Universal Trial Number (UTN)
U1111-1156-7707
Trial acronym
citalopram_cap
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 291880 0
Condition category
Condition code
Ear 292226 292226 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
citalopram 20 mg/day, in oral capsule, for 6 months;
Medical consultation every 2 months for drug delivery. At same time, the adherence will be evaluated as well as collateral effects or even other clinical benefits from the drug.
Intervention code [1] 289362 0
Treatment: Drugs
Comparator / control treatment
placebo (starch pills) /day, in oral capsule, for 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 292099 0
Improvement in Central Auditory Test (Pitch Pattern sequence, Dichotic Digit Test)
Timepoint [1] 292099 0
06 months
Secondary outcome [1] 308203 0
Patients handicap will be evaluated by Hearing Handicap Inventory for Elderly test (HHIE)
Timepoint [1] 308203 0
06 months
Secondary outcome [2] 308453 0
Cognitive status will be evaluated by Minimental Cognitive Test
Timepoint [2] 308453 0
06 months
Secondary outcome [3] 308454 0
Tinnitus will be evaluated by Tinnitus Handicap Inventory
Timepoint [3] 308454 0
06 months
Secondary outcome [4] 308455 0
Depression and humor status will be Beck Depression Inventory
Timepoint [4] 308455 0
06 months

Eligibility
Key inclusion criteria
Subjects with hearing threshold from normal to moderate loss and with low performance in central auditory processes tests.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications for the drug (citalopram).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2014
Actual
19/10/2015
Date of last participant enrolment
Anticipated
Actual
15/01/2016
Date of last data collection
Anticipated
Actual
15/08/2016
Sample size
Target
60
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 6049 0
Brazil
State/province [1] 6049 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 289223 0
Self funded/Unfunded
Name [1] 289223 0
Country [1] 289223 0
Primary sponsor type
Individual
Name
Jose Fernando Polanski
Address
Centro do Deficiente Auditivo - Federal University of Sao Paulo
Borges Lagoa street, number 783 - 2nd. floor
Vila Clementino - Sao Paulo - Sao Paulo
postal code 04038-031
Country
Brazil
Secondary sponsor category [1] 287894 0
None
Name [1] 287894 0
Address [1] 287894 0
Country [1] 287894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290990 0
Comite de Etica em Pesquisa - Unifesp/ hospital Sao Paulo
Ethics committee address [1] 290990 0
Botucatu street, number 572, 1st floor
Zip code 04023-061
Sao Paulo - Sao Paulo
Ethics committee country [1] 290990 0
Brazil
Date submitted for ethics approval [1] 290990 0
Approval date [1] 290990 0
01/02/2013
Ethics approval number [1] 290990 0
CAAE 11299413.5.0000.5505

Summary
Brief summary
Elderly with 60 years or more, with hearing impairment detected and confirmed by poor performance in Central Auditory Processing tests.
60 Subjects will be divided into two groups and given citalopram 20 mg/day or placebo for 6 months. Hearing evaluation will be performed initially and after 6 months and will include pure-tone audiometry, speech discrimination test (SDT), emittanciometry, hearing handicap inventory for elderly test (HHIE), minimental cognitive test and Central Auditory Processing evaluation.
Trial website
Trial related presentations / publications
Serotonin reuptake inhibitors in auditory processing disorders in elderly patients: preliminary results. Cruz OL, Kasse CA, Sanchez M, Barbosa F, Barros FA. Laryngoscope. 2004;114(9):1656-9.
Public notes

Contacts
Principal investigator
Name 48314 0
Dr Jose Fernando Polanski
Address 48314 0
Centro do Deficiente Auditivo - Federal University of Sao Paulo
Borges Lagoa street, number 783 - 2nd floor
Vila Clementino - Sao Paulo - SP
postal code 04038-031
Country 48314 0
Brazil
Phone 48314 0
+55 11 5576 4848 add 2427
Fax 48314 0
Email 48314 0
[email protected]
Contact person for public queries
Name 48315 0
Dr Jose Fernando Polanski
Address 48315 0
Centro do Deficiente Auditivo - Federal University of Sao Paulo
Borges Lagoa street, number 783 - 2nd floor
Vila Clementino - Sao Paulo - SP
postal code 04038-031
Country 48315 0
Brazil
Phone 48315 0
+55 11 5576 4848 add 2427
Fax 48315 0
Email 48315 0
[email protected]
Contact person for scientific queries
Name 48316 0
Dr Jose Fernando Polanski
Address 48316 0
Centro do Deficiente Auditivo - Federal University of Sao Paulo
Borges Lagoa street, number 783 - 2nd floor
Vila Clementino - Sao Paulo - SP
postal code 04038-031
Country 48316 0
Brazil
Phone 48316 0
+55 11 5576 4848 add 2427
Fax 48316 0
Email 48316 0
[email protected]

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.