DepressionPhase 3NCT02122393
A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
A Phase 3 study testing Sertraline and Cognitive Behavioural Therapy in people with Depression and Anxiety, run by University of Melbourne at 1 site in Australia.
Trial summary
Th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal depression. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Sertraline and Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2002to Apr 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with an infant > 2 months and < 8 months of age
- Infant born after a full-term pregnancy
- Infant born with no congenital abnormalities
- Diagnosis of depression with postnatal onset according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV).
Who cannot join
- positive serum pregnancy test;
- concurrent psychiatric disorder (excepting co-morbid anxiety);
- recent history of antidepressant usage (within the last month);
- history of major allergy or drug allergy;
- history of substance abuse;
- prior non-response to sertraline, or prior non-response to adequate trials of two selective serotonin reuptake inhibitors (SSRIs);
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- predisposition to headache, migraine or nausea;
- tobacco habit in excess of 10 cigarettes per day;
- caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per day;
- ongoing dental work;
- extreme levels of depression (psychotic);
- suicidal intent;
- participation in any medical trial within the previous three months;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal depression.
- Conditions
- Depression, Anxiety
- Being tested
- Sertraline, Cognitive Behavioural Therapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Cognitive Behavioural TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Active comparator | Not described Receives: Drug: Sertraline |
| Cognitive Behavioural Therapy | Active comparator | Not described Receives: Behavioral: Cognitive Behavioural Therapy |
| Combined Therapy | Active comparator | Not described Receives: Drug: Sertraline; Behavioral: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Measured: 24 weeks
Secondary outcomes (2)
Beck Anxiety Inventory
Measured: 24 weeks
Parenting Stress Index
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2002
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Jeannette Milgrom, University of Melbourne
- Investigators
- Jeannette Milgrom, PhD, Principal investigator, University of MelbourneAlan W Gemmill, PhD, Study director, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122393
- Sponsor's protocol ID
- H2001/01263
- Status last verified
- Apr 2014
- First submitted
- 22 Apr 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
- ClinicalTrials.gov ID
- NCT02122393
- Acronym / sponsor ID
- H2001/01263
- Conditions
- Depression, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Active comparator | Drug: Sertraline |
| Cognitive Behavioural Therapy | Active comparator | Behavioral: Cognitive Behavioural Therapy |
| Combined Therapy | Active comparator | Drug: Sertraline, Behavioral: Cognitive Behavioural Therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with an infant > 2 months and < 8 months of age
- Infant born after a full-term pregnancy
- Infant born with no congenital abnormalities
- Diagnosis of depression with postnatal onset according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV).
Key exclusion criteria (13 listed)
- positive serum pregnancy test;
- concurrent psychiatric disorder (excepting co-morbid anxiety);
- recent history of antidepressant usage (within the last month);
- history of major allergy or drug allergy;
- history of substance abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sertraline | Drug | Combined Therapy, Sertraline |
| Cognitive Behavioural Therapy | Behavioural | Cognitive Behavioural Therapy, Combined Therapy |
Primary outcome
Beck Depression Inventory
Time frame: 24 weeks
2 secondary outcomes
Beck Anxiety Inventory
Time frame: 24 weeks
Parenting Stress Index
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannette Milgrom, PhD principal investigator
University of Melbourne
Alan W Gemmill, PhD study director
Austin Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sertraline and Cognitive Behavioural Therapy in people with Depression and Anxiety, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.