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RecruitingPHASE3INTERVENTIONAL

The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

This study, called "INTENSIFY", explores different ways to treat bipolar depression, focusing on people whose first treatment hasn't worked well enough. Bipolar disorder causes big shifts in mood, energy, and daily function, with depression often being a major challenge. We know that many people with bipolar depression spend a lot of time feeling low, and current treatments don't always fully help. This research compares new treatment approaches, which might include different medications like escitalopram, lithium, or quetiapine, against the standard care. The goal is to discover if starting more intensive treatment earlier can lead to better outcomes for individuals struggling with bipolar depression, ultimately improving their quality of life.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Dr. Inge Winter
Enrolment target
418
Start
11 Feb 2025
Estimated completion
30 Jun 2028

What is this study about?

Bipolar disorder is a condition that causes significant shifts in a person's mood, energy, and ability to manage daily life. These shifts can range from periods of very high energy and excitement (mania or hypomania) to periods of deep sadness and low energy (depression). This study specifically focuses on bipolar depression, as many people find these depressive phases particularly difficult and long-lasting, often affecting their daily life more than other symptoms. Even with treatment, it's common for people to spend a lot of time feeling depressed.

Currently, there isn't one clear path for treating bipolar depression, and what works for one person might not work for another. Sometimes, the first treatment someone tries doesn't help enough, leaving them still struggling. This study is designed to explore if giving more focused or 'intensified' treatment earlier on, after the first treatment doesn't fully succeed, can make a difference. Researchers are comparing several established medications, such as escitalopram, lithium, and quetiapine, to see which approaches are most effective when someone isn't responding well to their initial treatment.

The "INTENSIFY" trial is part of a bigger research effort called Horizon 2021. The main aim of this larger project is to move towards more personalised treatment plans for individuals at risk of not responding to standard treatments for conditions like bipolar disorder, schizophrenia, and major depression. This specific study hopes to find clearer guidelines for doctors to decide when to introduce more intensive treatments earlier, helping people feel better sooner and improving their overall health and wellbeing.

Key takeaways

  • This study is for adults with bipolar depression whose initial treatment hasn't been fully effective.
  • It compares different medication approaches to see if intensified treatment helps earlier.
  • The goal is to improve treatment options and quality of life for people with bipolar depression.
  • Participation involves taking medication and attending regular check-ups over six weeks.
  • You have the right to withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with bipolar disorder type 1 or 2, currently experiencing a depressive episode. A key requirement is that your first treatment for this depression hasn't worked as well as hoped, and you and your doctor are open to trying a different treatment approach.

You also need to be experiencing a noticeable level of depressive symptoms and finding it hard to manage everyday activities due to your mood. A doctor will check these symptoms using specific scales. Female participants who could become pregnant must use effective birth control during the study, and male participants taking certain study medications will also need to use contraception.

However, you won't be able to join if you are pregnant or breastfeeding, or if you have known allergies to any of the medications being tested in the study. Similarly, if you have any medical conditions that would make taking these specific medications unsafe, you would not be eligible.

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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of bipolar disorder type 1 or 2, currently in a depressive phase?
  3. Has your first treatment for this current depressive episode not worked as well as you'd hoped?
  4. Are you experiencing significant depressive symptoms and struggling with daily activities?
  5. Are you able and willing to follow the study schedule and take the study medication?
  6. Are you not pregnant or breastfeeding, and for women, willing to use effective birth control?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a meeting where you'll sign consent forms and have your diagnosis and symptoms checked. This includes an interview and filling out some questionnaires. If you meet all the criteria, you'll be assigned to one of the treatment groups – either receiving a new, intensified medication plan or continuing with standard care. This will involve taking specific medications, which could include drugs like Escitalopram, Lithium, or Quetiapine, as chosen by the study team based on what's best for you.

Over six weeks, you will have several appointments (around 4-6 visits, some in person, some potentially by phone) where your doctors will monitor your symptoms, how you're feeling, and any side effects. You'll complete questionnaires at these visits to track your progress and wellbeing. The total duration of active treatment in the study is six weeks, after which your care will return to your regular doctor, but you might have some follow-up checks. All information gathered will be kept confidential.

Potential risks and benefits

Taking part in this study may offer various benefits, including closer monitoring of your condition and potentially access to different treatment strategies that might work better for you. However, as with any medication, there are potential risks, such as side effects from the study drugs. These side effects will be carefully monitored by the study team. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without needing to explain why, and this will not affect your usual medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Medical University Innsbruck
    Verified postcode
    Innsbruck, Austria· Recruiting
  • Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld
    Verified postcode
    Bielefeld, Germany· Recruiting
  • LWL-Klinik Dortmund, Bereich Forschung & Wissenschaft
    Verified postcode
    Dortmund, Germany· Recruiting
  • University Hospital Frankfurt am Main - Goethe University
    Verified postcode
    Frankfurt am Main, Germany· Recruiting
  • Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz
    Verified postcode
    Mainz, Germany· Recruiting
  • Westfälische Wilhelms-Universität Münster
    Verified postcode
    Münster, Germany· Recruiting
  • Eginition hospital, department of psychiatry
    Verified postcode
    Athens, Greece· Not yet recruiting
  • Universita degli Studi di Brescia
    Verified postcode
    Brescia, Italy· Recruiting
  • University of Cagliari
    Verified postcode
    Cagliari, Italy· Recruiting
  • Università degli studi della Campania Luigi Vanvitelli
    Verified postcode
    Naples, Italy· Recruiting
  • Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
    Verified postcode
    Turin, Italy· Recruiting
  • Fundació Clínic per a la Recerca Biomèdica
    Verified postcode
    Barcelona, Spain· Recruiting

Common questions

What is bipolar depression?

Bipolar depression is the 'low' phase of bipolar disorder, where people experience deep sadness, low energy, and difficulty with daily activities. It's often more challenging than the 'high' (manic or hypomanic) phases for many individuals.

Why is this study important?

This study aims to find better and faster ways to help people with bipolar depression whose first treatment didn't work well. It could lead to clearer guidance for doctors on when to try more focused treatments earlier.

What kind of treatments are being tested?

The study is looking at several existing medications, like escitalopram, sertraline, venlafaxine, lithium, valproate acid, quetiapine, and bupropion, to see which combinations or approaches work best.

Will I know which treatment I'm getting?

Some studies are 'blinded,' meaning you might not know if you're getting a new treatment specifically or standard care, to ensure results are fair. Your study doctor will explain this in detail.

How long will I be in the study?

The main treatment period for the study is six weeks, during which you'll have regular check-ups. There might be some follow-up contact after that.

How to find out more

Inge Winter, Dr.

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

Interested in taking part?

Register your interest

Share your details and the research team for "The Effect of a Six Week Intensified Pharmacological Treatme…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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