Study on the Effect of Citalopram, Sertraline, and Lithium for Patients with Bipolar Depression After First-Line Treatment Failure

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What is this study about?

This clinical trial is focused on studying the effects of a six-week intensified treatment for bipolar depression. Bipolar depression is a condition characterized by extreme mood swings, including emotional highs (mania or hypomania) and lows (depression). The study aims to compare this intensified treatment approach to the usual treatment methods for individuals who have not responded to their initial treatment. The medications involved in this study include escitalopram, sertraline, lithium, venlafaxine, quetiapine, sodium valproate, and bupropion. These medications are commonly used to manage symptoms of depression and mood disorders.

Participants in the study will receive either the intensified treatment or the usual treatment for a period of six weeks. The purpose of the study is to observe changes in the severity of depression symptoms and overall treatment response. The study will also monitor any side effects and changes in quality of life. The intensified treatment involves adjusting the medication regimen to better address the symptoms of bipolar depression, while the usual treatment follows standard practices.

The study will help determine if the intensified treatment is more effective than the usual treatment for individuals experiencing their first treatment failure. This information could be valuable in improving treatment strategies for bipolar depression in the future. Participants will be closely monitored throughout the study to ensure their safety and well-being. The study does not involve any invasive procedures, and all medications will be taken orally.

1 initial visit and consent

Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide written informed consent. This means you agree to participate in the study after understanding all the details.

If you are a female of childbearing potential, a pregnancy test will be conducted to ensure eligibility. Male participants using valproic acid must agree to use effective contraceptive measures during the trial.

2 baseline assessment

A baseline assessment will be conducted to evaluate your current symptoms. This will involve completing the Montgomery Åsberg Depression Rating Scale (MADRS) to measure the severity of your depression symptoms.

Additional assessments may include the Clinical Global Impression Scale (CGI) and the Sheehan Disability Scale (SDS) to evaluate functional impairment.

3 randomization and treatment

You will be randomly assigned to one of two groups: the early-intensified pharmacological treatment (EIPT) group or the treatment as usual (TAU) group.

If assigned to the EIPT group, you may receive medications such as escitalopram, sertraline, venlafaxine, quetiapine, sodium valproate, or bupropion hydrochloride. These medications are taken orally, and the specific dosage and frequency will be determined by the study team.

4 midpoint assessment

At the midpoint of the six-week treatment period, you will attend a follow-up visit. During this visit, your symptoms will be reassessed using the same scales as the baseline assessment.

This assessment helps to monitor your progress and any changes in symptom severity.

5 end of treatment assessment

At the end of the six-week treatment period, a final assessment will be conducted. This will include the MADRS, CGI, and other relevant scales to evaluate changes in your symptoms.

The study team will also assess any side effects you may have experienced during the trial.

6 post-treatment follow-up

After completing the treatment phase, you may be asked to attend additional follow-up visits. These visits are designed to monitor your long-term response to the treatment and any ongoing effects.

The study team will provide guidance on any further steps or treatments that may be necessary.

Who Can Join the Study?

Must be an inpatient (staying in a hospital) or outpatient (visiting a hospital or clinic but not staying overnight) and at least 18 years old.
Must be willing and able to provide written consent to participate. If you have a legal guardian, they can also sign the consent form.
If you are a female who can have children, you must use effective birth control during the trial and have a negative pregnancy test at the start. If you are a male using a medication called valproate acid, you must also use effective birth control measures during the trial.
Must have a primary diagnosis of bipolar depression (bipolar disorder type I or II currently in a depressive episode) confirmed by a specific interview called the Mini International Neuropsychiatric Interview (MINI).
Must be experiencing your first treatment failure because the current medication is not working. This medication should have been a first-choice treatment for bipolar depression and taken for at least 4 weeks at the recommended dose.
Must have failed the current medication for the current episode of bipolar depression, confirmed by a score of 3 or higher on a scale called the Clinical Global Impression-Improvement (CGI-I).
You and your doctor must plan to change your current medication.
Must have a certain level of symptom severity and experience difficulties in daily functioning. This means having a score of 20 or higher on the Montgomery Åsberg Depression Rating Scale (MADRS) and a score of 5 or higher on any of the three parts of the Sheehan Disability Scale (SDS).

Who Cannot Join the Study?

Patients who do not have a diagnosis of bipolar depression cannot participate.
Patients who have not experienced a first-time treatment failure on their first-line treatment for bipolar depression are excluded.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not willing or able to comply with the study procedures and requirements are excluded.
Patients with any other medical condition that the study team believes would interfere with the study results cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
University Of Brescia	Brescia	Italy
Eginitio Hospital	Athens	Greece
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
University Hospital Frankfurt am Main	Frankfurt	Germany
Lhdbndehoh Ddiqavpi	Dortmund	Germany
Uiamxqcjqzuzbjrqvb fic Pbbxrgmfrrv udt Pthzduzduulgqa Bzanckhua	Bielefeld	Germany
Kcmbta fix Pnxlnreaggx upg Puccnbwdwcifgx dpc Umvckiqwplkonygnjqo Mhkzv	Mainz	Germany
Cqvnzxw Pajeeilnalxpv 1lm fznho	Cagliari	Italy
Ahkkleg Ohlewopepvm Umiwpzxfjvggm Cayjhshnimvt Drkma Swdfag E Dgpee Ssfffvw Dd Tbbxoy	Turin	Italy

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.01.2024
Germany	Recruiting	01.01.2024
Greece	Not yet recruiting	01.01.2024
Italy	Recruiting	01.01.2024
Spain	Recruiting	01.01.2024

Trial locations

Investigated drugs:

Intensified Pharmacological Treatment is a special approach used in this clinical trial to help people with bipolar depression who did not respond well to their first treatment. This treatment involves using a combination of medications that are adjusted and intensified over a six-week period. The goal is to see if this approach can reduce the severity of depression symptoms more effectively than the usual treatment methods. Participants will have their symptoms measured at the beginning and end of the treatment to see how well this intensified approach works.

Bipolar Depression – Bipolar depression is a phase of bipolar disorder characterized by depressive episodes. During these episodes, individuals experience persistent feelings of sadness, hopelessness, and a lack of energy or interest in activities. The progression of bipolar depression can vary, with episodes lasting weeks to months. Symptoms may include changes in sleep patterns, appetite, and concentration. Unlike unipolar depression, bipolar depression is part of a cycle that includes periods of mania or hypomania. The condition can fluctuate, with periods of normal mood in between depressive and manic episodes.

Trial ID:

2023-506605-19-00

Protocol code:

INTENSIFY BD

NCT ID:

NCT05973786

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Citalopram, Sertraline, and Lithium for Patients with Bipolar Depression After First-Line Treatment Failure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?