Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01906905




Registration number
NCT01906905
Ethics application status
Date submitted
17/07/2013
Date registered
24/07/2013
Date last updated
3/04/2023

Titles & IDs
Public title
A Comparative Trial of TMS Approaches to Treating Depression
Scientific title
A Comparative Trial of TMS Approaches to Treating Depression
Secondary ID [1] 0 0
HC13053
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Transcranial Magnetic Stimulation - Active TMS (1)

Active comparator: Transcranial Magnetic Stimulation 2 - Active TMS (2)

Active comparator: Transcranial Magnetic Stimulation 3 - Active TMS (3)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery-Åsberg Depression Rating Scale(MADRS)
Timepoint [1] 0 0
Participants will be assessed for changes for duration of trial, an expected average of 6 weeks.

Eligibility
Key inclusion criteria
1. Age =18 years.
2. DSM-IV diagnosis of current Major Depressive Episode.
3. MADRS score of 20 or more.
4. Able to give informed consent.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. DSM-IV psychotic disorder.
2. Drug or alcohol abuse or dependence (preceding 3 months).
3. Inadequate response to ECT (current episode of depression).
4. Rapid clinical response required, e.g. high suicide risk.
5. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
6. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
7. Pregnancy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute, University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2052 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Colleen Loo, MB.BS. (Hons), FRANZCP, MD.
Address 0 0
Black Dog Institute, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

TypeCitations or Other Details
Journal George MS, Lisanby SH, Avery D, McDonald WM, Durka... [More Details]
Journal Loo CK, McFarquhar TF, Mitchell PB. A review of th... [More Details]
Journal Nahas Z, Bohning DE, Molloy MA, Oustz JA, Risch SC... [More Details]
Journal O'Reardon JP, Solvason HB, Janicak PG, Sampson S, ... [More Details]
Journal Padberg F, Zwanzger P, Keck ME, Kathmann N, Mikhai... [More Details]
Journal Pascual-Leone A, Rubio B, Pallardo F, Catala MD. R... [More Details]
Journal Pascual-Leone A, Valls-Sole J, Wassermann EM, Hall... [More Details]
Journal Slotema CW, Blom JD, Hoek HW, Sommer IE. Should we... [More Details]
Journal Speer AM, Benson BE, Kimbrell TK, Wassermann EM, W... [More Details]
Journal Wassermann EM. Risk and safety of repetitive trans... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01906905