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.
NCT ID: NCT05973786
Last Updated: 2025-09-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
418 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-02-11
Study Completion Date
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs. Bipolar disorder I and II represent disorders that cause extreme fluctuation in a person's mood, energy, and ability to function, in which symptoms of (hypo)mania and depression alternate. The depressive episodes of bipolar disorders are often referred to as bipolar depression (BD). In other words: it is a phase/state of the disorder. For many patients with BD, the depressive polarity is often more pervasive and more debilitating than manic states, with estimates that depressed mood accounts for up to two-thirds of the time spent unwell, even with treatment. The burden of not received an effective treatment for BD is high: more severe psychopathology, higher rates of unemployment, more hospitalisations, lower quality of life, lower cognitive functioning, risk of suicide, comorbidities and poorer social and occupational functioning and thus more carer burden. For BD, the treatment guidelines are very heterogeneous, amongst other reasons because the disease is heterogeneous and treatments should be tailored to the patients. There is no clear treatment algorithm and it cannot yet be predicted which treatment will be effective. Especially the place of adjunctive antidepressants is under debate. Usually, for psychiatric disorders (including bipolar disorder), a patient is considered to be treatment-resistant is two medicinal treatments have been tried (in sufficient duration and dosage) without sufficient success. For BD, there is no consensus on when to consider a patient as treatment-resistant, but the most common definition is after one prior treatment failure. This raises the research question whether adjunctive antidepressants to treat BD should be introduced earlier in the treatment. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
NCT00177567
Bipolar Disorder
COMPLETED
PHASE4
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
NCT02893371
Bipolar Disorder
TERMINATED
Does Bipolar Disease Program (BDP) Intervention Improve Long Term Manic and Depressive Symptoms.
NCT00007761
Bipolar Disorder
COMPLETED
PHASE3
Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder
NCT01663974
Bipolar Disorder
Sub-syndromal Symptoms
TERMINATED
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
NCT05328297
Bipolar Disorder
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Rationale Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs. Bipolar disorder I and II represent disorders that cause extreme fluctuation in a person's mood, energy, and ability to function, in which symptoms of (hypo)mania and depression alternate. The depressive episodes of bipolar disorders are often referred to as bipolar depression (BD). In other words: it is a phase/state of the disorder. For many patients with BD, the depressive polarity is often more pervasive and more debilitating than manic states, with estimates that depressed mood accounts for up to two-thirds of the time spent unwell, even with treatment. The burden of not received an effective treatment for BD is high: more severe psychopathology, higher rates of unemployment, more hospitalisations, lower quality of life, lower cognitive functioning, risk of suicide, comorbidities and poorer social and occupational functioning and thus more carer burden. For BD, the treatment guidelines are very heterogeneous, amongst other reasons because the disease is heterogeneous and treatments should be tailored to the patients. There is no clear treatment algorithm and it cannot yet be predicted which treatment will be effective. Especially the place of adjunctive antidepressants is under debate. Usually, for psychiatric disorders (including bipolar disorder), a patient is considered to be treatment-resistant is two medicinal treatments have been tried (in sufficient duration and dosage) without sufficient success. For BD, there is no consensus on when to consider a patient as treatment-resistant, but the most common definition is after one prior treatment failure. This raises the research question whether adjunctive antidepressants to treat BD should be introduced earlier in the treatment. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.
Objective The primary objective is to compare the treatment response (baseline; visit 2 vs. end of treatment; visit 4), expressed as symptom severity at six weeks and changes in symptom severity from baseline, as measured through the Montgomery-Åsberg Depression Rating Scale (MADRS) under an early-intensified pharmacological treatment to that under treatment as usual, in subjects who had a first-time treatment failure on their first-line treatment.
Main trial endpoints Change in symptom severity total score from baseline (visit 2) to end of treatment (visit 4). This is measured using MADRS.
Secondary trial endpoints
1. To compare changes in severity and improvement in global functioning assessed by the Clinical Global Impression Scale (CGI) between the two treatment arms.
2. To compare changes in the levels of depression and anxiety between treatment arms.
3. To compare changes in quality of life and functioning measures between treatment arms.
4. To compare changes in cognitive performance between treatment arms.
5. To compare the proportion of participants (EIPT vs. TAU) that is in symptomatic remission at visit 4.
6. To compare presence of side effects between treatment arms.
7. To compare use of concomitant medication between treatment arms.
8. To compare premature discontinuation (timing and reason) between treatment arms.
9. To compare changes in suicidal ideation between treatment arms.
10. To compare occurrence of (hypo)manic episode during the study between the treatment arms.
Trial design The clinical study is an international, multicenter controlled, randomised, open label trial (with blinded raters), with a treatment duration of six weeks.
Trial population The aim is to recruit 418 subjects with bipolar disorder type I or II, currently in a depressive episode. Male and female subjects, in- and out-patients, with the age of at least 18 old are eligible for participation. The main exclusion criteria are defined to protect the wellbeing of subjects, e.g. being pregnant or breastfeeding, subjects with previous failure on quetiapine, meeting any contraindications, or participants with a known intolerance to quetiapine.
Interventions
Subjects are randomised to treatment as usual (second-line treatment) or to the early-intensified pharmacological treatment (third-line treatment). Treatment per can be found in the table below:
Table 1. Overview of treatment randomisation per study sample.
Treatment as Usual (TAU) Switch to quetiapine plus lithium or valproate acid Early-Intensified Pharmacological Treatment (EIPT) Switch to
1. one of the following: escitalopram, sertraline, bupropion or venlafaxine plus
2. two of the following: lithium, valproate acid or quetiapine
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of subjects represented by the trial subjects as well as the nature and extent of burden and risks All medications studied in the current trial are widely used (alone or in combination) in clinical practice and the risks for side effects are well established. In the current study, clinical practice is mimicked as much as possible to maximize generalisability and for feasibility purposes. To this end, Summaries of Product Characteristics (SmPCs) are followed with regards to contraindications (implemented as exclusion criterion), safety measures and allowed combinations with other medications. Site visits and assessments are kept to a minimum to keep subject burden at an acceptable level, while meeting the objectives of the study. Blood samples for biomarker analyses are only collected when subjects provide consent; safety measures are performed as part of clinical routine.
Overall, the risks are similar to daily clinical practice; the only difference relative to clinical practice is the application of three pharmacological treatments (EIPT) versus two (TAU) earlier in the illness. Still, these additional treatment options are also commonly prescribed by clinicians. There are no indications in existing literature or clinical practice that the earlier introduction of these medications poses a safety risk when used in an earlier illness phase than indicated in the SmPC.
A benefit of the study is that if it indeed turns out that the early-intensified treatment is associated with more symptom improvement compared to treatment as usual, future patients have to go through less trial and error, which results in a reduced burden (higher quality of life, less unemployment, less hospitalisations) for patients and carers as well as lower societal and healthcare costs.
IMPORTANT: the study was submitted to the European authorities before (see NCT05603104) and they requested to split this study into 3 studies (1 for each diagnostic category). We have done this and created 3 new ClinicalTrials.gov studies as well, from which this is one for bipolar depression. The ClinicalTrials.gov numbers of the related trials are NCT05958875 for the INTENSIFY SZ trial and NCT05973851 for the INTENSIFY MDD trial. The site in the UK (London) followed the advice and will submit 3 separate protocols and are therefore included in the current record. However, Israel already submitted this as one protocol. Therefore, we keep the old clinicaltrials.gov number for Israel (NCT05603104).
Objective The primary objective is to compare the treatment response (baseline; visit 2 vs. end of treatment; visit 4), expressed as symptom severity at six weeks and changes in symptom severity from baseline, as measured through the Montgomery-Åsberg Depression Rating Scale (MADRS) under an early-intensified pharmacological treatment to that under treatment as usual, in subjects who had a first-time treatment failure on their first-line treatment.
Main trial endpoints Change in symptom severity total score from baseline (visit 2) to end of treatment (visit 4). This is measured using MADRS.
Secondary trial endpoints
1. To compare changes in severity and improvement in global functioning assessed by the Clinical Global Impression Scale (CGI) between the two treatment arms.
2. To compare changes in the levels of depression and anxiety between treatment arms.
3. To compare changes in quality of life and functioning measures between treatment arms.
4. To compare changes in cognitive performance between treatment arms.
5. To compare the proportion of participants (EIPT vs. TAU) that is in symptomatic remission at visit 4.
6. To compare presence of side effects between treatment arms.
7. To compare use of concomitant medication between treatment arms.
8. To compare premature discontinuation (timing and reason) between treatment arms.
9. To compare changes in suicidal ideation between treatment arms.
10. To compare occurrence of (hypo)manic episode during the study between the treatment arms.
Trial design The clinical study is an international, multicenter controlled, randomised, open label trial (with blinded raters), with a treatment duration of six weeks.
Trial population The aim is to recruit 418 subjects with bipolar disorder type I or II, currently in a depressive episode. Male and female subjects, in- and out-patients, with the age of at least 18 old are eligible for participation. The main exclusion criteria are defined to protect the wellbeing of subjects, e.g. being pregnant or breastfeeding, subjects with previous failure on quetiapine, meeting any contraindications, or participants with a known intolerance to quetiapine.
Interventions
Subjects are randomised to treatment as usual (second-line treatment) or to the early-intensified pharmacological treatment (third-line treatment). Treatment per can be found in the table below:
Table 1. Overview of treatment randomisation per study sample.
Treatment as Usual (TAU) Switch to quetiapine plus lithium or valproate acid Early-Intensified Pharmacological Treatment (EIPT) Switch to
1. one of the following: escitalopram, sertraline, bupropion or venlafaxine plus
2. two of the following: lithium, valproate acid or quetiapine
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of subjects represented by the trial subjects as well as the nature and extent of burden and risks All medications studied in the current trial are widely used (alone or in combination) in clinical practice and the risks for side effects are well established. In the current study, clinical practice is mimicked as much as possible to maximize generalisability and for feasibility purposes. To this end, Summaries of Product Characteristics (SmPCs) are followed with regards to contraindications (implemented as exclusion criterion), safety measures and allowed combinations with other medications. Site visits and assessments are kept to a minimum to keep subject burden at an acceptable level, while meeting the objectives of the study. Blood samples for biomarker analyses are only collected when subjects provide consent; safety measures are performed as part of clinical routine.
Overall, the risks are similar to daily clinical practice; the only difference relative to clinical practice is the application of three pharmacological treatments (EIPT) versus two (TAU) earlier in the illness. Still, these additional treatment options are also commonly prescribed by clinicians. There are no indications in existing literature or clinical practice that the earlier introduction of these medications poses a safety risk when used in an earlier illness phase than indicated in the SmPC.
A benefit of the study is that if it indeed turns out that the early-intensified treatment is associated with more symptom improvement compared to treatment as usual, future patients have to go through less trial and error, which results in a reduced burden (higher quality of life, less unemployment, less hospitalisations) for patients and carers as well as lower societal and healthcare costs.
IMPORTANT: the study was submitted to the European authorities before (see NCT05603104) and they requested to split this study into 3 studies (1 for each diagnostic category). We have done this and created 3 new ClinicalTrials.gov studies as well, from which this is one for bipolar depression. The ClinicalTrials.gov numbers of the related trials are NCT05958875 for the INTENSIFY SZ trial and NCT05973851 for the INTENSIFY MDD trial. The site in the UK (London) followed the advice and will submit 3 separate protocols and are therefore included in the current record. However, Israel already submitted this as one protocol. Therefore, we keep the old clinicaltrials.gov number for Israel (NCT05603104).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Bipolar Depression
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel randomization to the 2 arms, treatment as usual (TAU) or early-intensified pharmacological treatment (EIPT).
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Open label, except for the assessors of the primary outcome
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bipolar Depression EIPT: Switch to one of the following combinations:
Bipolar Depression randomized to EIPT: Switch to 1. one of the following: escitalopram, sertraline, bupropion or venlafaxine plus 2. two of the following: lithium, valproate acid or quetiapine
Group Type
EXPERIMENTAL
Escitalopram
Intervention Type
DRUG
See arm description
Sertraline
Intervention Type
DRUG
See arm description
Venlafaxine
Intervention Type
DRUG
See arm description
Lithium
Intervention Type
DRUG
See arm description
Valproate acid
Intervention Type
DRUG
See arm description
Quetiapine
Intervention Type
DRUG
See arm description
Bupropion
Intervention Type
DRUG
See arm description
Bipolar Depression TAU: Switch to quetiapine plus lithium or valproate acid
Bipolar Depression randomized to TAU: Switch to quetiapine plus lithium or valproate acid Compound, brand, dosage, frequency and duration up to the investigator's discretion (in accordance with SmPC).
Group Type
ACTIVE_COMPARATOR
Lithium
Intervention Type
DRUG
See arm description
Valproate acid
Intervention Type
DRUG
See arm description
Quetiapine
Intervention Type
DRUG
See arm description
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Escitalopram
See arm description
Intervention Type
DRUG
Sertraline
See arm description
Intervention Type
DRUG
Venlafaxine
See arm description
Intervention Type
DRUG
Lithium
See arm description
Intervention Type
DRUG
Valproate acid
See arm description
Intervention Type
DRUG
Quetiapine
See arm description
Intervention Type
DRUG
Bupropion
See arm description
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
ATC code: N06AB10
ATC code: N06AB06
ATC code: N06AX16
ATC code: N05AN01
ATC code: N03AG01
ATC code: N05AH04
ATC cose: N06AX12
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. In- or out patients, at least 18 years of age.
2. Being willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure.
3. Female subjects of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should have a negative pregnancy test at visit 1 or 2 (before randomisation). Male subjects that will use valproate acid during the trial must use effective contraceptive measures during the trial (see section 8.2.1).
4. Meeting diagnostic criteria for a primary diagnosis of bipolar depression (bipolar disorder type I and II currently in a depressive episode), according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).
5. Subject experiences a treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3; preferably, this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics (SmPCs). However, other lines of treatment are accepted as well.
6. Subject and clinician intend to change pharmacotherapeutic treatment.
7. A minimum symptom severity threshold needs to be present (moderate leve) and subject needs to experience functional impairment.
* The minimum symptom severity threshold is a score of ≥20 on the Montgomery Åsberg Depression Rating Scale (MADRS)
* Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).
2. Being willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure.
3. Female subjects of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should have a negative pregnancy test at visit 1 or 2 (before randomisation). Male subjects that will use valproate acid during the trial must use effective contraceptive measures during the trial (see section 8.2.1).
4. Meeting diagnostic criteria for a primary diagnosis of bipolar depression (bipolar disorder type I and II currently in a depressive episode), according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).
5. Subject experiences a treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3; preferably, this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics (SmPCs). However, other lines of treatment are accepted as well.
6. Subject and clinician intend to change pharmacotherapeutic treatment.
7. A minimum symptom severity threshold needs to be present (moderate leve) and subject needs to experience functional impairment.
* The minimum symptom severity threshold is a score of ≥20 on the Montgomery Åsberg Depression Rating Scale (MADRS)
* Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).
Exclusion Criteria
1. Being pregnant or breastfeeding.
2. Subject has a known intolerance to quetiapine or to all EIPT medication or to all TAU medication.
3. Meeting any of the contraindications for quetiapine, or to all EIPT medication or to all TAU medication options, as specified within the applicable SmPC, supported by clinically significant abnormal values on local laboratory tests, electrocardiogram (ECG) or physical examinations.
4. Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1.
5. Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the trial, or may influence the result of the trial, or the subject's ability to participate in the trial.
6. Subjects with active suicidal ideation with some intent to act, without specific plan ("Yes" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent ("Yes" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study.
7. Subject meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and/or cannabis use disorder are not allowed.
8. Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
9. A score of 12 or higher on the Young Mania Rating Scale (YMRS) in order to exclude subjects with predominant manic symptoms or mixed symptoms.
10. Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance.
11. Subjects with pre-existing severe liver damage (as tested within the local laboratory test at visit 1).
12. Subjects with a history of antidepressant-induced mania or hypomania or recent rapid cycling (based on the medical file of the potential participant or the clinical judgment of the clinician).
2. Subject has a known intolerance to quetiapine or to all EIPT medication or to all TAU medication.
3. Meeting any of the contraindications for quetiapine, or to all EIPT medication or to all TAU medication options, as specified within the applicable SmPC, supported by clinically significant abnormal values on local laboratory tests, electrocardiogram (ECG) or physical examinations.
4. Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1.
5. Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the trial, or may influence the result of the trial, or the subject's ability to participate in the trial.
6. Subjects with active suicidal ideation with some intent to act, without specific plan ("Yes" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent ("Yes" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study.
7. Subject meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and/or cannabis use disorder are not allowed.
8. Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
9. A score of 12 or higher on the Young Mania Rating Scale (YMRS) in order to exclude subjects with predominant manic symptoms or mixed symptoms.
10. Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance.
11. Subjects with pre-existing severe liver damage (as tested within the local laboratory test at visit 1).
12. Subjects with a history of antidepressant-induced mania or hypomania or recent rapid cycling (based on the medical file of the potential participant or the clinical judgment of the clinician).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universität Münster
OTHER
Sponsor Role
collaborator
Dr. Inge Winter
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Inge Winter
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University Innsbruck
Innsbruck, , Austria
Site Status
RECRUITING
Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld
Bielefeld, , Germany
Site Status
RECRUITING
LWL-Klinik Dortmund, Bereich Forschung & Wissenschaft
Dortmund, , Germany
Site Status
RECRUITING
University Hospital Frankfurt am Main - Goethe University
Frankfurt am Main, , Germany
Site Status
RECRUITING
Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz
Mainz, , Germany
Site Status
RECRUITING
Westfälische Wilhelms-Universität Münster
Münster, , Germany
Site Status
RECRUITING
Eginition hospital, department of psychiatry
Athens, , Greece
Site Status
NOT_YET_RECRUITING
Universita degli Studi di Brescia
Brescia, , Italy
Site Status
RECRUITING
University of Cagliari
Cagliari, , Italy
Site Status
RECRUITING
Università degli studi della Campania Luigi Vanvitelli
Naples, , Italy
Site Status
RECRUITING
Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
Turin, , Italy
Site Status
RECRUITING
Fundació Clínic per a la Recerca Biomèdica
Barcelona, , Spain
Site Status
RECRUITING
King's College London, Psychiatry & Cognitive Neuroscience
London, , United Kingdom
Site Status
NOT_YET_RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Austria
Germany
Greece
Italy
Spain
United Kingdom
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-506605-19-00 (EU CT#)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
NCT00958633
TERMINATED
PHASE3
Effect of Quetiapine on Brain Activity Patterns in Patients With Heightened Risk of Bipolar Disorder
NCT02451306
UNKNOWN
NA
Antidepressant Therapy in Treating Bipolar Type II Major Depression
NCT00602537
COMPLETED
PHASE4
A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
NCT00938301
COMPLETED
PHASE1
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
NCT05169710
TERMINATED
PHASE3
Prevention of Relapse & Recurrence of Bipolar Depression
NCT00961961
COMPLETED
PHASE4
A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
NCT03543410
COMPLETED
PHASE2
Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression
NCT00879372
UNKNOWN
PHASE3
An Epidemiological Registry Study to Evaluate Clinical Practice Treatment in Patients With Bipolar Disorder
NCT01455961
COMPLETED
Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
NCT00562861
COMPLETED
PHASE2/PHASE3
Acute Treatment of Bipolar II Depression
NCT00074776
COMPLETED
PHASE3
Depression And Bipolar Disorder
NCT00274677
COMPLETED
PHASE3
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
NCT06433635
ACTIVE_NOT_RECRUITING
PHASE4
Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression
NCT00475137
COMPLETED
PHASE2
Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms
NCT00277667
COMPLETED
PHASE3
Simvastatin Augmentation of Lithium Treatment in Bipolar Depression
NCT01665950
TERMINATED
PHASE2
Antidepressant Therapy for Bipolar II Major Depression
NCT00641927
COMPLETED
PHASE4
Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients
NCT02466685
COMPLETED
PHASE2
Mindfulness Based Cognitive Therapy for Bipolar Disorder
NCT03507647
COMPLETED
NA
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
NCT00194116
COMPLETED
PHASE3
Group Dialectical Behavioural Therapy for Mood Instability Within Bipolar Disorder: An Open Trial
NCT02637401
COMPLETED
To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.
NCT06429722
COMPLETED
PHASE2
Imaging 5HT7 Antagonist Effects in Bipolar Disorder
NCT03633357
UNKNOWN
NA
Olanzapine/Fluoxetine Combination Versus Comparator in the Treatment of Bipolar I Depression
NCT00485771
COMPLETED
PHASE4
Guidance Model of Standardized Treatment of Antidepressants in Bipolar Disorder
NCT03148535
UNKNOWN
PHASE4