Major Depressive DisorderCogMiNDNCT05802966
Cognition in Mindfulness: Negativity and Depression
An observational study of Major Depressive Disorder, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
Mindfulness-Based Cognitive Therapy (MBCT) is effective in reducing relapse rates and (residual) symptoms in major depressive disorder (MDD). However, the mechanisms underlying those MBCT-induced effects are far from clear. The goal of this study is to get more insight into the working mechanisms of MBCT. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- 2 sitesNetherlands
- Study dates
- 24 Jun 2019to 28 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic or recurrent MDD who are referred for MBCT at the RadboudUMC Centre for Mindfulness or at different locations of a local mental health institute (Pro Persona) will be recruited for the current study. Those patients will follow regular medical intake-procedures in accordance to procedures at the respective institutes and are screened for chronic or recurrent depression and other in- and exclusion criteria. Depression will be considered chronic if patients meet the DSM-V criteria of a 'persistent depressive disorder', which is combination of the 'chronic depressive disorder' and 'dysthymic disorder' as defined in the DSM-IV.
Who may be able to join
- age ≥ 18
- diagnosis of chronic or recurrent MDD according to DSM-V criteria, both current or remitted
- able to give informed consent and perform experimental tasks
Who cannot join
- in remission of first (not chronic) episode or having a first (not chronic) current episode
- insufficient comprehension of the Dutch language
- physical, cognitive, or intellectual impairments interfering with participation such as deafness, blindness, or sensorimotor handicaps
- formerly involved in MBCT or MBSR or other 8-week Mindfulness-Based Intervention (MBI)
- meets criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective illness or anorexia nervosa
- current psychosis
- high level of suicidality
- drug or alcohol addiction in the past 6 months.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Pro Persona
Nijmegen, Gelderland, 6503CG
Radboud University Medical Centre
Nijmegen, Gelderland, P.O. Box 9101
About this study
Mindfulness-Based Cognitive Therapy (MBCT) is effective in reducing relapse rates and (residual) symptoms in major depressive disorder (MDD). However, the mechanisms underlying those MBCT-induced effects are far from clear. The goal of this study is to get more insight into the working mechanisms of MBCT. The main question to be answered is whether MBCT-induced reduction in depressive symptoms is mediated and/or moderated by repetitive negative thinking (RNT), or other factors hypothesized to be involved in the working mechanism of MBCT (e.g. mindfulness skills and self-compassion).
Read the detailed description
Introduction
Depression is highly prevalent and is ranked by the world health organization (WHO) as the number one contributor to disability worldwide. The highly recurrent nature of the disorder contributes greatly to the burden of Major Depressive Disorder (MDD) and with every new depressive episode, outcome prospective worsen. Mindfulness Based Cognitive Therapy (MBCT) is an effective treatment to reduce relapse rates and (residual) symptoms that contribute to recurrence in MDD. However, the mechanisms underlying this MBCT-induced effect are far from clear.
Elucidating these mechanisms will provide insight in the existing individual differences in effectiveness of MBCT. Consequently, this insight will help to improve effectiveness of treatment and even personalize treatment regimes. One likely candidate that could play a major role in the positive effects of MBCT on depressive symptoms, is repetitive negative thinking (RNT). Depressive rumination is the most well-studied form in the context of depression and has been described as the process of thinking perseveratively about one's feelings and problems (such as symptoms of depression) and their possible causes and consequences. It is believed that during MBCT participants develop the ability to become aware of automatic maladaptive cognitive processes such as depressive rumination, and learn to decenter and disengage from them. Because of this core skill to be learned during MBCT patients may be prevented to enter a vicious cycle of ruminative thinking that could otherwise aggravate symptoms of depression or have resulted in a new depressive episode.
Objectives
Our main objectives are (i) to replicate the beneficial effects of MBCT on depressive symptoms and RNT in patients with chronic or recurrent depression (crMDD), and (ii) to investigate whether individual levels of RNT (iia) mediate and/or (iib) moderate the MBCT-induced reduction in depressive symptoms.
To this end self-report questionnaires of depressive symptoms, content-independent RNT and depressive rumination will be administered before, half-way and after MBCT (intervention group) or before, half-way and after a waiting-period (waitlist group).
Secondary objectives
To triangulate research findings an experimental task (breathing focus task) that measures intrusive thoughts during task performance will be administered.
Moreover, research will focus on cognitive control and affective biases therein, because this process is related to RNT. Two major constituents of cognitive control will be measured, i.e. working memory processing and motivational biases of cognitive control (with respectively a working-memory update/ignore emotion task and Pavlovian-to-instrumental transfer task) before and after MBCT/waitlist. This behavioural data will be used to assess whether working memory and motivational biases are indeed (i) related to RNT and MDD, (ii) are changed by MBCT and (iii) whether these changes are related to clinical effects of MBCT.
Additionally, the timing of change will be investigated by administering weekly self-report questionnaires.
Design:
A multicenter, wait-list controlled-trial, with assignment to an intervention group (MBCT + treatment as usual (TAU)) or waitlist-control group (TAU) based on date of intake and start date of MBCT. Thus, assignment is not randomized and the study does not interfere with regular clinical practice (e.g. planning MBCT). If patients have to wait > 7 weeks for the next MBCT, they are invited to participate in the wait-list group while patients that have to wait < 7 weeks will be assigned to the intervention group. Note that although a full MBCT-training training lasts 8 weeks, for feasibility a cut-off of 7 weeks instead of 8 was deliberately chosen because this allows us to assign more patients to the wait-list group. This was done to prevent (as much as possible) an anticipated skewed allocation in favour of the intervention group.
Healthy controls will be invited to one measurement as a benchmark for the innovative cognitive tasks and do not follow MBCT.
Statistical analysis:
A detailed description of the planned analyses can be found within the attached Statistical Analysis Plan.
- Conditions
- Major Depressive Disorder
- Being tested
- Mindfulness-Based Cognitive Therapy
- Keywords
- Major Depressive Disorder, Mindfulness-Based Cognitive Therapy, Working mechanisms
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
MBCT will be offered according to the MBCT manual developed for relapse prevention in MDD (Zindel V. Segal, Williams, \& Teasdale, 2002). Thus, MBCT will consist of 8-weekly sessions of 2,5 hours, a 6-hour silent day, and daily home practice (± 45min). MBCT will be taught by a certified MBCT teacher meeting the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders (Belgium) which are in concordance with the Good Practice guidelines of the UK Network of Mindfulness-Based Teacher Trainers (Crane et al., 2012).
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment as usual | Patients receive Mindfulness-Based Cognitive Therapy (MBCT) and treatment as usual (TAU). Measurements are administered before, half-way and after MBCT. Receives: Behavioral: Mindfulness-Based Cognitive Therapy | |
| Wait-list control (Treatment as usual) | Patients in the wait-list controlled group receive treatment us usual (TAU) during their waiting-period. After their waiting period, they receive MBCT in a similar fashion compared to the intervention group. Measurements are administered before, half-way and after their waiting period. In addition, a fourth and fifth measurement will be administered half-way and after MBCT. Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured with the Inventory of Depressive Symptomatology Self-Report (IDS-SR). The IDS-SR consists of 30 items. Scores range from 0-84. Higher scores indicate a higher severity of depression.
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Depressive rumination
Measured with the brooding subscale of the Ruminative Response Scale (RRS). The brooding subscale consists of 5 items. Scores range from 5-20. Higher scores indicate a higher level of depressive rumination.
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Repetitive negative thinking (RNT)
Measured by the Perseverative Thinking Questionnaire (PTQ). The PTQ consists of 15 items. Scores range from 0-60. Higher scores indicate a higher level of repetitive negative thinking.
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Secondary outcomes (7)
Intrusive thoughts (state measure)
Measured with the breathing focus task (BFT) that measures negative, positive and neutral thoughts during task performance
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Mindfulness Skills
Measured with the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF). This questionnaire is divided into the subscales observing (4 items), and describing, acting with awareness, non-judging and non-reactivity (all 5 items). The facets scores will be calculated by determining the mean of corresponding item scores. Negatively-phrased items will be reversed scored before computing the mean scores of the subscales. Subscale scores range from 1-5, with higher scores indicating 'higher/better' ability of mindfulness on the corresponding domain.
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Anxiety Symptoms
Measured with the Spielberger State-Trait Anxiety Inventory (STAI). The STAI consists of 20 items. Scores range from 20-80. Higher scores indicate a higher severity of anxiety.
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Overall functioning
Measured with the Outcome Questionnaire - 45 (OQ-45). The OQ-45 consists of 45 items. Scores range from 0-180. Higher scores indicate higher symptom severity.
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Self-compassion
Measured with the Self Compassion Scale - Short form (SCS-SF). The scale consists of six subscales each containing 2 items: self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification. The negatively phrased items will be reversed-scored before calculating subscale and total scores. Each subscale ranges from 2-14. A higher score indicates a higher level (better outcome) of self-kindness, common humanity, mindfulness, self-judgment, isolation, and over-identification. Total scores range from 12 to 84 (summed subscale scores), a higher score indicates a higher level of self-compassion.
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Influence of Pavlovian information on goal-directed behaviour
Measured with the Pavlovian to Instrumental Transfer (PIT) task
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Working memory - emotion-dependent update and ignore capacity of working memory
Measured with the Working Memory Update/Ignore Emotion Task (WMUIET)
Measured: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start24 Jun 2019
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Why it stopped: No (financial) means left to continue inclusion to achieve predetermined sample size. Instead of continuation (high probability of unanalyzed data) it was decided to stop inclusion and analyze data, so the scientific community can benefit from it.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pro Persona Mental Health Care Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802966
- Sponsor's protocol ID
- NL68398.091.18
- Acronym
- CogMiND
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The authors intend to make the data available to other researchers after completion of the study and will comply with open access procedures, including open access publishing, as much as possible.
Publications
Lubbers J, Geurts DEM, Spinhoven P, Cladder-Micus MB, Ennen D, Speckens AEM, Spijker J. Rumination and Self-Compassion Moderate Mindfulness-Based Cognitive Therapy for Patients With Recurrent and Persistent Major Depressive Disorder: A Controlled Trial. Depress Anxiety. 2024 Nov 25;2024:3511703. doi: 10.1155/da/3511703. eCollection 2024.
PubMed 40226644
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition in Mindfulness: Negativity and Depression
- ClinicalTrials.gov ID
- NCT05802966
- Acronym / sponsor ID
- CogMiND / NL68398.091.18
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Mindfulness-Based Cognitive Therapy, Working mechanisms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No (financial) means left to continue inclusion to achieve predetermined sample size. Instead of continuation (high probability of unanalyzed data) it was decided to stop inclusion and analyze data, so the scientific community can benefit from it.
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Pro Persona Mental Health Care Foundation
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mindfulness-Based Cognitive Therapy (MBCT) is effective in reducing relapse rates and (residual) symptoms in major depressive disorder (MDD). However, the mechanisms underlying those MBCT-induced effects are far from clear. The goal of this study is to get more insight into the working mechanisms of MBCT. The main question to be answered is whether MBCT-induced reduction in depressive symptoms is mediated and/or moderated by repetitive negative thinking (RNT), or other factors hypothesized to be involved in the working mechanism of MBCT (e.g. mindfulness skills and self-compassion).
Detailed description
Introduction
Depression is highly prevalent and is ranked by the world health organization (WHO) as the number one contributor to disability worldwide. The highly recurrent nature of the disorder contributes greatly to the burden of Major Depressive Disorder (MDD) and with every new depressive episode, outcome prospective worsen. Mindfulness Based Cognitive Therapy (MBCT) is an effective treatment to reduce relapse rates and (residual) symptoms that contribute to recurrence in MDD. However, the mechanisms underlying this MBCT-induced effect are far from clear.
Elucidating these mechanisms will provide insight in the existing individual differences in effectiveness of MBCT. Consequently, this insight will help to improve effectiveness of treatment and even personalize treatment regimes. One likely candidate that could play a major role in the positive effects of MBCT on depressive symptoms, is repetitive negative thinking (RNT). Depressive rumination is the most well-studied form in the context of depression and has been described as the process of thinking perseveratively about one's feelings and problems (such as symptoms of depression) and their possible causes and consequences. It is believed that during MBCT participants develop the ability to become aware of automatic maladaptive cognitive processes such as depressive rumination, and learn to decenter and disengage from them. Because of this core skill to be learned during MBCT patients may be prevented to enter a vicious cycle of ruminative thinking that could otherwise aggravate symptoms of depression or have resulted in a new depressive episode.
Objectives
Our main objectives are (i) to replicate the beneficial effects of MBCT on depressive symptoms and RNT in patients with chronic or recurrent depression (crMDD), and (ii) to investigate whether individual levels of RNT (iia) mediate and/or (iib) moderate the MBCT-induced reduction in depressive symptoms.
To this end self-report questionnaires of depressive symptoms, content-independent RNT and depressive rumination will be administered before, half-way and after MBCT (intervention group) or before, half-way and after a waiting-period (waitlist group).
Secondary objectives
To triangulate research findings an experimental task (breathing focus task) that measures intrusive thoughts during task performance will be administered.
Moreover, research will focus on cognitive control and affective biases therein, because this process is related to RNT. Two major constituents of cognitive control will be measured, i.e. working memory processing and motivational biases of cognitive control (with respectively a working-memory update/ignore emotion task and Pavlovian-to-instrumental transfer task) before and after MBCT/waitlist. This behavioural data will be used to assess whether working memory and motivational biases are indeed (i) related to RNT and MDD, (ii) are changed by MBCT and (iii) whether these changes are related to clinical effects of MBCT.
Additionally, the timing of change will be investigated by administering weekly self-report questionnaires.
Design:
A multicenter, wait-list controlled-trial, with assignment to an intervention group (MBCT + treatment as usual (TAU)) or waitlist-control group (TAU) based on date of intake and start date of MBCT. Thus, assignment is not randomized and the study does not interfere with regular clinical practice (e.g. planning MBCT). If patients have to wait > 7 weeks for the next MBCT, they are invited to participate in the wait-list group while patients that have to wait < 7 weeks will be assigned to the intervention group. Note that although a full MBCT-training training lasts 8 weeks, for feasibility a cut-off of 7 weeks instead of 8 was deliberately chosen because this allows us to assign more patients to the wait-list group. This was done to prevent (as much as possible) an anticipated skewed allocation in favour of the intervention group.
Healthy controls will be invited to one measurement as a benchmark for the innovative cognitive tasks and do not follow MBCT.
Statistical analysis:
A detailed description of the planned analyses can be found within the attached Statistical Analysis Plan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy + Treatment as usual | – | Behavioral: Mindfulness-Based Cognitive TherapyPatients receive Mindfulness-Based Cognitive Therapy (MBCT) and treatment as usual (TAU). Measurements are administered before, half-way and after MBCT. |
| Wait-list control (Treatment as usual) | – | Behavioral: Mindfulness-Based Cognitive TherapyPatients in the wait-list controlled group receive treatment us usual (TAU) during their waiting-period. After their waiting period, they receive MBCT in a similar fashion compared to the intervention group. Measurements are administered before, half-way and after their waiting period. In addition, a fourth and fifth measurement will be administered half-way and after MBCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic or recurrent MDD who are referred for MBCT at the RadboudUMC Centre for Mindfulness or at different locations of a local mental health institute (Pro Persona) will be recruited for the current study. Those patients will follow regular medical intake-procedures in accordance to procedures at the respective institutes and are screened for chronic or recurrent depression and other in- and exclusion criteria. Depression will be considered chronic if patients meet the DSM-V criteria of a 'persistent depressive disorder', which is combination of the 'chronic depressive disorder' and 'dysthymic disorder' as defined in the DSM-IV.
Key inclusion criteria (3 listed)
- age ≥ 18
- diagnosis of chronic or recurrent MDD according to DSM-V criteria, both current or remitted
- able to give informed consent and perform experimental tasks
Key exclusion criteria (8 listed)
- in remission of first (not chronic) episode or having a first (not chronic) current episode
- insufficient comprehension of the Dutch language
- physical, cognitive, or intellectual impairments interfering with participation such as deafness, blindness, or sensorimotor handicaps
- formerly involved in MBCT or MBSR or other 8-week Mindfulness-Based Intervention (MBI)
- meets criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective illness or anorexia nervosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive TherapyMBCT will be offered according to the MBCT manual developed for relapse prevention in MDD (Zindel V. Segal, Williams, \& Teasdale, 2002). Thus, MBCT will consist of 8-weekly sessions of 2,5 hours, a 6-hour silent day, and daily home practice (± 45min). MBCT will be taught by a certified MBCT teacher meeting the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders (Belgium) which are in concordance with the Good Practice guidelines of the UK Network of Mindfulness-Based Teacher Trainers (Crane et al., 2012). | Behavioural | Mindfulness-Based Cognitive Therapy + Treatment as usual, Wait-list control (Treatment as usual) |
Primary outcome
Depressive symptoms
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Measured with the Inventory of Depressive Symptomatology Self-Report (IDS-SR). The IDS-SR consists of 30 items. Scores range from 0-84. Higher scores indicate a higher severity of depression.
Depressive rumination
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Measured with the brooding subscale of the Ruminative Response Scale (RRS). The brooding subscale consists of 5 items. Scores range from 5-20. Higher scores indicate a higher level of depressive rumination.
Repetitive negative thinking (RNT)
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Measured by the Perseverative Thinking Questionnaire (PTQ). The PTQ consists of 15 items. Scores range from 0-60. Higher scores indicate a higher level of repetitive negative thinking.
7 secondary outcomes
Intrusive thoughts (state measure)
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Mindfulness Skills
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Anxiety Symptoms
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Overall functioning
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Self-compassion
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Influence of Pavlovian information on goal-directed behaviour
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Working memory - emotion-dependent update and ignore capacity of working memory
Time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)
Results and safety
The study was stopped early (reason given: No (financial) means left to continue inclusion to achieve predetermined sample size. Instead of continuation (high probability of unanalyzed data) it was decided to stop inclusion and analyze data, so the scientific community can benefit from it.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 40226644Lubbers J, Geurts DEM, Spinhoven P, Cladder-Micus MB, Ennen D, Speckens AEM, Spijker J. Rumination and Self-Compassion Moderate Mindfulness-Based Cognitive Therapy for Patients With Recurrent and Persistent Major Depressive Disorder: A Controlled Trial. Depress Anxiety. 2024 Nov 25;2024:3511703. doi: 10.1155/da/3511703. eCollection 2024.
- Individual participant dataSharing planned: Yes. The authors intend to make the data available to other researchers after completion of the study and will comply with open access procedures, including open access publishing, as much as possible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No (financial) means left to continue inclusion to achieve predetermined sample size. Instead of continuation (high probability of unanalyzed data) it was decided to stop inclusion and analyze data, so the scientific community can benefit from it.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Change from baseline to mid-treatment (4 weeks), to post-treatment (8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.