RecruitingPHASE4INTERVENTIONAL

Personalized Indications for CBT and Antidepressants in Treating Depression

This research is trying to figure out the best way to treat depression for each individual. While both talking therapies (like Cognitive Behavioural Therapy) and antidepressant medications can help, they don't work for everyone. Sometimes, both are given together, but this study suggests that certain people might respond better to one over the other. Researchers believe that things like childhood experiences, how active someone feels, or even specific markers in the body (like inflammation or insulin resistance) could help predict which treatment will be most effective for a particular person. The goal is to create a more personalised approach to depression treatment, leading to better results and more efficient care.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Nova Scotia Health Authority

Enrolment target

Start

31 Oct 2016

Estimated completion

01 Jun 2027

Major Depressive Disorder Persistent Depressive Disorder

What is this study about?

Depression is a common illness that affects many people in the UK. While there are good treatments available, such as talking therapies (like Cognitive Behavioural Therapy, or CBT) and antidepressant medications, they don't always work perfectly for everyone. In fact, many people don't get the full benefit from their first treatment. This can be frustrating and means people might spend a long time trying different options.

This study aims to make treatment more effective by understanding the specific factors that influence how well someone responds to different treatments. Researchers have noticed that combining talking therapy and medication often works better than just one alone. However, they wonder if this is because some people respond better to medication and others to talking therapy, and giving both at once means everyone gets what they need, rather than both being essential for *everyone*.

To figure this out, the study will look at several things. These include a person's childhood experiences, how much they've lost interest in activities, and certain markers in their body that can be found with blood tests, like inflammation or how their body handles sugar (insulin resistance). The researchers think these factors might help predict whether someone will benefit more from antidepressants or from talking therapy. If they can accurately predict this, it would allow doctors to suggest the most suitable treatment from the start, leading to better and faster recovery for people with depression.

Key takeaways

The study aims to find the *best* individual treatment for depression.
It compares antidepressant medication and talking therapies (like CBT).
Researchers are looking at past experiences, current symptoms, and body markers to guide treatment.
The goal is more personalised, effective care for depression.
Participation involves assessments and receiving one of the study treatments.

Who may be eligible?

To join this study, you would need to be 18 years old or older and have been diagnosed with either Major Depressive Disorder or Persistent Depressive Disorder. Your depression needs to be the main health concern you're dealing with, and it should be at a certain level of severity, lasting for at least two months.

There are also some reasons why you might not be able to join. For example, if you've been diagnosed with certain other mental health conditions like bipolar disorder or schizophrenia, or if you're pregnant. You also wouldn't be able to join if you've recently had a lot of talking therapy (10 or more sessions in the last year) or recently started new antidepressant medication or significantly changed your dose in the last few weeks.

Finally, if you've tried two or more of the types of medications used in the study before and they didn't work for you, or if you are currently experiencing active suicidal thoughts or psychotic symptoms, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Major Depressive Disorder or Persistent Depressive Disorder?
Is your depression currently the main health problem you're dealing with?
Have you *not* recently changed antidepressant medication or had extended talking therapy?
Are you *not* pregnant or diagnosed with bipolar disorder or schizophrenia?
Do you *not* have active suicidal thoughts or psychotic symptoms?

Answer every question to see your result.

What does participation involve?

The study is designed to help researchers learn which treatments work best for different people with depression. If you take part, you would be carefully assessed to understand your specific type of depression and other health factors. This would likely involve talking with doctors, filling out questionnaires, and potentially having some blood tests to check for certain markers in your body. Based on these assessments, you would then receive either antidepressant medication or cognitive behavioural therapy (CBT), or a combination, depending on what the study design indicates. Researchers would then monitor your progress closely over time to see how well the treatment is working for you. The exact number of visits, tests, and the total duration aren't fully detailed here, but these would be clearly explained to you before you decide to participate.

Potential risks and benefits

Taking part in a study like this isn't without its considerations. A potential benefit is receiving carefully monitored treatment for your depression, which could lead to an improvement in your symptoms and overall well-being sooner than might happen if you were to try different treatments without this guided approach. However, there are also potential risks; for example, the treatment you receive might not work for you, or you might experience side effects from medication or discomfort during therapy sessions. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Nova Scotia Health Authority
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is Cognitive Behavioral Therapy (CBT)?

CBT is a common type of talking therapy that helps you understand how your thoughts and behaviours affect your feelings. It provides practical ways to manage problems and improve your mood.

What does 'pharmacotherapy' mean?

'Pharmacotherapy' is simply a medical term for treatment using medication, in this case, antidepressant medications for depression.

Why are blood tests part of the study?

Blood tests are used to look for specific substances in your body, like inflammation markers, that researchers believe might influence how well a particular treatment works for depression.

What is the 'Phase 4' of a clinical trial?

Phase 4 means the treatment (antidepressants, CBT) is already approved and widely available. This phase looks at how to best use these treatments in everyday situations, focusing on long-term effects and personalised approaches.

Will I know which treatment I'll receive before I join?

The study aims to *predict* which treatment is best. You'll be assessed first, and the study design will determine how treatment decisions are made. All details will be fully explained before you agree to take part.

How to find out more

Rudolf Uher, MD, PhD

rudolf.uher@nshealth.ca 1-902-473-7209 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.