Trial Review

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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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00168493




Registration number
NCT00168493
Ethics application status
Date submitted
10/09/2005
Date registered
15/09/2005
Date last updated
20/05/2008

Titles & IDs
Public title
The Neurobiology of Depressive Illness
Scientific title
The Neurobiology of Depressive Illness: Causes and Consequences of Altered Brain Monoaminergic Function
Secondary ID [1] 0 0
NHMRC D-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - antidepressants primarily selective serotonin reuptake inhibitors

Active comparator: intervention - there is no sham or placebo control arm It is a single arm study


Treatment: Drugs: antidepressants primarily selective serotonin reuptake inhibitors
normal clinical dosages used according to clinical response as determined by a psychiatrist
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
level of sympathetic nervous system activity and its response to treatment
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
clinical response to treatment
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
* Major depression
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* heart disease diabetes hypertension psychosis significant suicidal risk dementia

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2009
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Murray A Esler, MBBS Phd
Address 0 0
Baker Heart Research Insitute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David A Barton, MBBSFRANZCP
Address 0 0
Country 0 0
Phone 0 0
61393428946
Fax 0 0
Email 0 0
[email protected]
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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00168493