Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000831280
Ethics application status
Approved
Date submitted
22/05/2009
Date registered
23/09/2009
Date last updated
23/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Perinatal treatment of depression
Scientific title
Maternal and infant outcomes following antenatal exposure to specific serotonin reuptake inhibitor (SSRI) and serotonin and noradrenaline reuptake inhibitor (SNRI )medications
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal depression 4840 0
Condition category
Condition code
Mental Health 237183 237183 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will wean antidepressnt medication between 35 and 37 weeks of pregnancy, and then restart at one week post partum. The medications given will be any SSRI/SNRI medications given orally at dosage equivalents of up to 60mg of citalopram daily or 375mg of Venlafaxine daily. In many cases the participants will already be on the medications prior to being enrolled in the trial. In the group that weans they will continue their medication on a daily basis for as long as clinically indicated; usually at least twelve months post partum
Intervention code [1] 236619 0
Treatment: Drugs
Comparator / control treatment
Comparison groups - One group to wean and cease antidepressants at 35 weeks of pregnancy and one group to continue to term; group that weans will recommence antidepressant treatment at one week post partum and continue for as long as clinically indicated, usually at least telve months post partum.
Also control group of general population antenatal patients not receiving antidepressant therapy
Control group
Active

Outcomes
Primary outcome [1] 238001 0
Maternal mental health as measured by depression rating scales Montgomery Asberg Depression Rating Scale(MADRS ) and Edinburgh Postnatal Depression Scale (EPND)
Timepoint [1] 238001 0
K28 ( 28 weeks pregnant), K38 (38 weeks pregnant), 3 days, 3 weeks, 3 months and 6 months post partum
Secondary outcome [1] 242135 0
Signs of foetal discontinuation as measured by Finnegan neonatal abstinence score and objective motion sensors
Timepoint [1] 242135 0
Day 1 to 4 post delivery

Eligibility
Key inclusion criteria
Pregnant, on SSRI/SNRI medications
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Comorbid substance abuse, use of benzodiazepines, and history of or current suicidality

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)
Subjects enrolled by psychiatrist and clinical nurse consultant running trial; single blinded in that research assistants doing the outcome measures will be blind to treatment group. Subjects allocated using randomization generated by statistician external to trial
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
Simple randomization using computer generated sequence
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4999 0
Hospital
Name [1] 4999 0
Royal Brisbane Hospital
Country [1] 4999 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane Hospital
Address
Butterfield St
Herston Qld 4006
Country
Australia
Secondary sponsor category [1] 4520 0
None
Name [1] 4520 0
Address [1] 4520 0
Country [1] 4520 0
Other collaborator category [1] 676 0
University
Name [1] 676 0
University of Queensland, School of Medicine, Department of Psychiatry
Address [1] 676 0
Butterfield St
Herston Qld 4006
Country [1] 676 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7101 0
Royal Brisbane Hospital
Ethics committee address [1] 7101 0
Butterfield St
Herston Qld 4006
Ethics committee country [1] 7101 0
Australia
Date submitted for ethics approval [1] 7101 0
Approval date [1] 7101 0
Ethics approval number [1] 7101 0
2008/066

Summary
Brief summary
Purpose of the study is to examine mother and baby outcomes following exposure to antidepressant medication during pergnancy. Patients will be asked to either continue antidepressant medication up until and after delivery; or to wean medication at 35 weeks of pregnancy and recommence at one week post partum. The primary hypothesis is the women who continue their medication through delivery will have fewer depressive symptoms. The secondary hypothesis is that babies exposed to antidepressant medication to term will be more likely to have discontinuation symptoms such as jitteriness and irritability
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29635 0
Address 29635 0
Country 29635 0
Phone 29635 0
Fax 29635 0
Email 29635 0
Contact person for public queries
Name 12882 0
Dr Sally Matheson
Address 12882 0
Royal Brisbane Hospital
Butterfield St
Herston Qld 4006
Country 12882 0
Australia
Phone 12882 0
+61736362505
Fax 12882 0
+61736362511
Email 12882 0
Sally_Matheson@health.qld.gov.au
Contact person for scientific queries
Name 3810 0
Dr Sally Matheson
Address 3810 0
Royal Brisbane Hospital
Butterfield St
Herston Qld 406
Country 3810 0
Australia
Phone 3810 0
+617 36362505
Fax 3810 0
+61736362511
Email 3810 0
Sally_Matheson@health.qld.gov.au

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.