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New treatment option for Major Depressive Disorder
Official title Personalized Indications for CBT and Antidepressants in Treating Depression
ClinicalTrials.gov ID: NCT02752542
What this study is testing
What is Pharmacotherapy?
Pharmacotherapy is an investigational medicine, given as an once-daily, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Depression currently affects close to 2 million Canadians and is the leading cause of disability worldwide. Pharmacological treatments (antidepressant medication) and psychological treatments such as cognitive-behavioural therapy are available for depression, but the majority of those who receive treatment have an unsatisfactory response.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5), and depression being the primary problem requiring...
- a minimum current severity of 14 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
- a cumulative duration of depression of at least two months (this will exclude short-lasting first depressive episodes that do not require treatment...
- capacity to provide informed consent.
You likely can't join if
- lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or current alcohol or drug use disorder
- pregnancy
- recent receipt of adequate trial of psychological treatment (10 or more sessions in the past 12 months)
- recently introduced antidepressant medication (new antidepressant in past 12 weeks or dose increase in the past 6 weeks)
- previous non-response to two or more of study medications
- acute suicide risk (MADRS suicide item≥4)
See the full eligibility criteria
- a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5), and depression being the primary problem requiring clinical attention (judgement of intake clinician).
- a minimum current severity of 14 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
- a cumulative duration of depression of at least two months (this will exclude short-lasting first depressive episodes that do not require treatment of this intensity), age 18 or more (no upper limit)
- capacity to provide informed consent.
- lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or current alcohol or drug use disorder
- pregnancy
- recent receipt of adequate trial of psychological treatment (10 or more sessions in the past 12 months)
- recently introduced antidepressant medication (new antidepressant in past 12 weeks or dose increase in the past 6 weeks)
- previous non-response to two or more of study medications
- acute suicide risk (MADRS suicide item≥4)
- current psychotic symptoms.
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halifax, Nova Scotia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.