Depressive DisorderPhase 4PRECISERNCT05768126
Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
A Phase 4 study testing Rivastigmine Transdermal Product in people with Depressive Disorder, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to test the beneficial effects of rivastigmine administration, and predict the treatment outcome with electroencephalography (EEG), in patients with severe depression treated with electroconvulsive therapy (ECT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Rivastigmine Transdermal Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Sep 2021to Jan 2026
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Clinical indication for ECT (as indicated by the treating physician/psychiatrist)
- Uni- or bipolar depression (as assessed by the treating psychiatrist)
- Fluent in Dutch
Who cannot join
- Currently receiving, or having received ECT 6 months prior to the start of the treatment/study.
- Currently using rivastigmine, galantamine, donepezil (all cholinesterase inhibitors for mild to moderate Alzheimer's Disease).
- Pregnancy and/or lactation/breast feeding
- Suspicion of neurodegenerative disorders (as diagnosed earlier)
- Contraindications for ECT (recent myocardial infarction, recent cerebrovascular accident, recent intracranial surgery, pheochromocytoma and instable angina pectoris)
- Contraindications for rivastigmine (bradycardia or atrioventricular (AV) conduction disorders (first degree AV-block excluded)
- Patients who have had an allergic reaction to rivastigmine
- Cognitive disorder not explained by the depressive episode
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Jasper O. Nuninga, Dr., +31639139525, j.o.nuninga@umcg.nl
Jesca E. de Jager, MSc., +31637423121, j.e.de.jager@umcg.nl
About this study
The goal of this clinical trial is to test the beneficial effects of rivastigmine administration, and predict the treatment outcome with electroencephalography (EEG), in patients with severe depression treated with electroconvulsive therapy (ECT). The study has two main objectives:
- to study whether rivastigmine would ameliorate the side-effect profile of ECT
- to develop an outcome prediction model based on resting state EEG for both the response to treatment as well as its side effect
Read more
Participants will be assessed by:
- Cognitive tests
- Questionnaires of clinical symptoms
- Questionnaires of depressive symptoms
- Bloodsample
- Resting state and task-based EEG
Researchers will compare patients with a depressive disorder treated with ECT receiving rivastigmine to placebo patches to see if rivastigmine reduces cognitive side effects.
Read the detailed description
Electroconvulsive therapy (ECT) is the most potent psychiatric treatment, with an effect size of 1.5 for severe and refractory unipolar and bipolar depression. ECT convincingly outperforms pharmacotherapy such as tricyclic antidepressants and monoamine oxidase inhibitors and any form of psychotherapy. Despite its outstanding performance in reducing depressive symptoms up to the point of full remission, it is used only marginally. One reason for its infrequent use may be that the response to ECT is largely unpredictable, while cognitive side-effects occur frequently.
In a previous study, the researchers found that multiple cognitive tests showed a significant decline immediately post-ECT, which resolved within 6 months after the last ECT session without further treatment. Even though cognitive side-effects are mostly short-lasting, both patients and doctors see this as a great drawback of ECT. If these disturbing side-effects could be prevented, more patients and psychiatrists would choose ECT as a treatment option. This would lead to a more effective treatment and hence shorter duration of chronic severe depression and improvement in quality of life, while costs for health care and loss of productivity would decrease. A potential way of ameliorating side effects, could be to add a cholinesterase inhibitor to ECT treatment. Rodent studies show that the loss of cholinergic fibers specifically correlated to the cognitive side effects of rodents after electroconvulsive stimulation (ECS). The researchers selected rivastigmine (a cholinesterase inhibitor) as a potential candidate in counteracting cognitive side effects induced by cholinergic fiber loss due to ECT. Rivastigmine patches are very well tolerated and widely used for Alzheimer's and Parkinson's dementia.
Tailoring treatment to patients that are likely to respond while cognitive side-effects are unlikely to occur, would be another important improvement for depressed patients. Currently, ECT outcome is unpredictable. Factors that favor response include older age, psychotic depression, shorter duration of the depressive episode, and smaller volumes of the dentate gyrus (a part of the hippocampus). However, these predictors do not provide enough accuracy to make individual response profiles. Accurately classifying specifically non-responders will prevent application of ineffective treatment with potential iatrogenic damage, while more accurately predicted response will increase the applicability of ECT as treatment option. A potentially powerful way that is easy to implement in the clinic is prediction of ECT response using resting state EEG characteristics in addition to clinical information.
- Conditions
- Depressive Disorder
- Being tested
- Rivastigmine Transdermal Product, Sham
- Keywords
- electroconvulsive therapy, rivastigmine, EEG
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine Transdermal ProductDrug
The patches will be administered (first four weeks 4.6 mg and then 9.5. mg).
ShamOther
The sham patches will be administered during the same period of time as the rivastigmine.
| Study group | Role | What they receive |
|---|---|---|
| Rivastigmine | Experimental | Rivastigmine, transdermal administration with a dosage of 4.6 and 9.6mg. The patches will be administered daily. The duration will equate to the duration of ECT treatment (that will be clinically determined) Receives: Drug: Rivastigmine Transdermal Product |
| Sham | Sham comparator | Non-active patches will be administered daily. The duration will equate to the duration of ECT treatment (that will be clinically determined) Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of rivastigmine on scores of the verbal fluency test.
Changes in cognitive functioning as measured by scores on the Verbal fluency test, in which participants are asked to pronounce as many words (0 - infinity) as possible in 60 seconds in a certain category or starting with a certain letter. A higher score means a better outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
The effect of rivastigmine on scores of the Rey auditory verbal learning test
Changes in cognitive functioning as measured by scores on the Rey auditory verbal learning test, in which the assessor reads a list of of 15 words to the participant, and the participant is asked to repeat as many words as they remember. This is repeated 5 times (learning) and 15 minutes later the participant is asked how many words (0-15 words) they remember (memory). The scale ranges from 0-90 words in total. A higher score means a better outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
The effect of rivastigmine on changes in scores on the Montreal Cognitive Assessment
Changes in cognitive functioning as measured by scores on the Montreal Cognitive Assessment, that comprises of assessing multiple cognitive domains with a scoring scale of 0-30. A higher score means a better outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
The effect of rivastigmine on changes in scores on the Columbia University Autobiographical Memory Interview short form
Changes in cognitive functioning before, during and after treatment as measured by scores on the Columbia University Autobiographical Memory Interviewshort form. The subject's ability to remember the specific details originally provided during the pre-treatment interview is measured on a scale of 0-60 points. A higher score means a better outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in resting-state EEG peak frequency
To develop an outcome prediction model the investigators will use resting state EEG output in units of peak frequency
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Treatment response
Treatment response defined as 50% symptom reduction as measured with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.
Measured: Baseline
Treatment response
Treatment response defined as 50% symptom reduction as measured with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.
Measured: Within 72 hours after the first treatment session
Treatment response
Treatment response defined as 50% symptom reduction as measured with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.
Measured: Within 1 week after the last treatment session
Treatment response
Treatment response defined as 50% symptom reduction as measured with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.
Measured: At 3-months after the last treatment session
Remission
with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome. Remission as measured by a score of <7.
Measured: Baseline
Remission
with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome. Remission as measured by a score of <7.
Measured: Within 72 hours after the first treatment session
Remission
with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome. Remission as measured by a score of <7.
Measured: Within 1 week after the last treatment session
Remission
with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.Remission as measured by a score of <7.
Measured: At 3-months after the last treatment session
Secondary outcomes (10)
Quality of life of patients assessed with the European Quality of Life Five Dimensions with Five Levels (Euro-QoL-5D-5L)
The assessment of the quality of life of patients during the study, it comprises of 5 questions, measured on a scale of 5-25. A higher score means a worse outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Quality of life of patients assessed with the visual analog scale of the European Quality of Life Five Dimensions with Five Levels (Euro-QoL-5D-5L)
The assessment of the quality of life of patients during the study. The instrument includes a visual analog scale (VAS) anchored by 0 (worst imaginable health) and 100 (best imaginable health). A higher score means a better outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in the global assessment of disability using the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12 item version
The assessment of global disability of the patients during the study, measured on a scale of 12-60. A higher score means a worse outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in peak amplitude measured with selective attention EEG task
The selective attention tasks measures behavioral outcomes by hits/misses/false alarms.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in behavioral outcome measured with the selective attention EEG task
The selective attention task measures behavioral outcomes by hits/misses/false alarms.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in processing negativity measured with the selective attention EEG task
The selective attention task measures behavioral outcomes by hits/misses/false alarms.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in mismatch negativity measures (amplitude, latency and duration) obtained with the MisMatch Negativity Paradigm during an EEG recoding
The mismatch negativity task measures event-related potentials by EEG and the Mismatch Negativity Paradigm
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Change in subjective feeling of memory impairment on the Subjective Assessment of Memory Impairment (SAMI) questionnaire
The Subjective Assessment of Memory Impairment is a questionnaire that comprises of two questions of which the first question concerns the subjective feeling of memory point, rated on a 10-point likert scale, and is rated from 0 no impairment, to 10 severe impairment. A higher score means a worse outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Change in impact of cognitive adverse events on the Subjective Assessment of Memory Impairment (SAMI) questionnaire
The Subjective Assessment of Memory Impairment is a questionnaire that comprises of two questions of which the second question concerns the impact of cognitive adverse events, on a 5-point likert scale, rated from 1 no complaints, to 5 severe complaints. A higher score means a worse outcome.
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in the Expectation of response form
The likelihood that they will recover questioned by a scale with a range from -5 (negative effect expected) to 5 (positive effect expected)
Measured: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start29 Sep 2021
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, St. Antonius Hospital, Tergooi Hospital
- Responsible party
- Principal investigator, Iris Sommer, University Medical Center Groningen
- Investigators
- Iris EC Sommer, PhD, MD, Principal investigator, UMC Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768126
- Sponsor's protocol ID
- 202000842
- Acronym
- PRECISER
- Status last verified
- May 2024
- First submitted
- 26 Aug 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
- ClinicalTrials.gov ID
- NCT05768126
- Acronym / sponsor ID
- PRECISER / 202000842
- Conditions
- Depressive Disorder
- Keywords
- electroconvulsive therapy, rivastigmine, EEG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, St. Antonius Hospital, Tergooi Hospital
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Mar 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.
The goal of this clinical trial is to test the beneficial effects of rivastigmine administration, and predict the treatment outcome with electroencephalography (EEG), in patients with severe depression treated with electroconvulsive therapy (ECT). The study has two main objectives:
- to study whether rivastigmine would ameliorate the side-effect profile of ECT
- to develop an outcome prediction model based on resting state EEG for both the response to treatment as well as its side effect
Participants will be assessed by:
- Cognitive tests
- Questionnaires of clinical symptoms
- Questionnaires of depressive symptoms
- Bloodsample
- Resting state and task-based EEG
Researchers will compare patients with a depressive disorder treated with ECT receiving rivastigmine to placebo patches to see if rivastigmine reduces cognitive side effects.
Detailed description
Electroconvulsive therapy (ECT) is the most potent psychiatric treatment, with an effect size of 1.5 for severe and refractory unipolar and bipolar depression. ECT convincingly outperforms pharmacotherapy such as tricyclic antidepressants and monoamine oxidase inhibitors and any form of psychotherapy. Despite its outstanding performance in reducing depressive symptoms up to the point of full remission, it is used only marginally. One reason for its infrequent use may be that the response to ECT is largely unpredictable, while cognitive side-effects occur frequently.
In a previous study, the researchers found that multiple cognitive tests showed a significant decline immediately post-ECT, which resolved within 6 months after the last ECT session without further treatment. Even though cognitive side-effects are mostly short-lasting, both patients and doctors see this as a great drawback of ECT. If these disturbing side-effects could be prevented, more patients and psychiatrists would choose ECT as a treatment option. This would lead to a more effective treatment and hence shorter duration of chronic severe depression and improvement in quality of life, while costs for health care and loss of productivity would decrease. A potential way of ameliorating side effects, could be to add a cholinesterase inhibitor to ECT treatment. Rodent studies show that the loss of cholinergic fibers specifically correlated to the cognitive side effects of rodents after electroconvulsive stimulation (ECS). The researchers selected rivastigmine (a cholinesterase inhibitor) as a potential candidate in counteracting cognitive side effects induced by cholinergic fiber loss due to ECT. Rivastigmine patches are very well tolerated and widely used for Alzheimer's and Parkinson's dementia.
Tailoring treatment to patients that are likely to respond while cognitive side-effects are unlikely to occur, would be another important improvement for depressed patients. Currently, ECT outcome is unpredictable. Factors that favor response include older age, psychotic depression, shorter duration of the depressive episode, and smaller volumes of the dentate gyrus (a part of the hippocampus). However, these predictors do not provide enough accuracy to make individual response profiles. Accurately classifying specifically non-responders will prevent application of ineffective treatment with potential iatrogenic damage, while more accurately predicted response will increase the applicability of ECT as treatment option. A potentially powerful way that is easy to implement in the clinic is prediction of ECT response using resting state EEG characteristics in addition to clinical information.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivastigmine | Experimental | Drug: Rivastigmine Transdermal ProductRivastigmine, transdermal administration with a dosage of 4.6 and 9.6mg. The patches will be administered daily. The duration will equate to the duration of ECT treatment (that will be clinically determined) |
| Sham | Sham comparator | Other: ShamNon-active patches will be administered daily. The duration will equate to the duration of ECT treatment (that will be clinically determined) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Clinical indication for ECT (as indicated by the treating physician/psychiatrist)
- Uni- or bipolar depression (as assessed by the treating psychiatrist)
- Fluent in Dutch
Key exclusion criteria (8 listed)
- Currently receiving, or having received ECT 6 months prior to the start of the treatment/study.
- Currently using rivastigmine, galantamine, donepezil (all cholinesterase inhibitors for mild to moderate Alzheimer's Disease).
- Pregnancy and/or lactation/breast feeding
- Suspicion of neurodegenerative disorders (as diagnosed earlier)
- Contraindications for ECT (recent myocardial infarction, recent cerebrovascular accident, recent intracranial surgery, pheochromocytoma and instable angina pectoris)
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 |
|---|---|---|
| Rivastigmine Transdermal ProductThe patches will be administered (first four weeks 4.6 mg and then 9.5. mg). | Drug | Rivastigmine |
| ShamThe sham patches will be administered during the same period of time as the rivastigmine. | Other | Sham |
Primary outcome
The effect of rivastigmine on scores of the verbal fluency test.
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in cognitive functioning as measured by scores on the Verbal fluency test, in which participants are asked to pronounce as many words (0 - infinity) as possible in 60 seconds in a certain category or starting with a certain letter. A higher score means a better outcome.
The effect of rivastigmine on scores of the Rey auditory verbal learning test
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in cognitive functioning as measured by scores on the Rey auditory verbal learning test, in which the assessor reads a list of of 15 words to the participant, and the participant is asked to repeat as many words as they remember. This is repeated 5 times (learning) and 15 minutes later the participant is asked how many words (0-15 words) they remember (memory). The scale ranges from 0-90 words in total. A higher score means a better outcome.
The effect of rivastigmine on changes in scores on the Montreal Cognitive Assessment
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in cognitive functioning as measured by scores on the Montreal Cognitive Assessment, that comprises of assessing multiple cognitive domains with a scoring scale of 0-30. A higher score means a better outcome.
The effect of rivastigmine on changes in scores on the Columbia University Autobiographical Memory Interview short form
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in cognitive functioning before, during and after treatment as measured by scores on the Columbia University Autobiographical Memory Interviewshort form. The subject's ability to remember the specific details originally provided during the pre-treatment interview is measured on a scale of 0-60 points. A higher score means a better outcome.
Changes in resting-state EEG peak frequency
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
To develop an outcome prediction model the investigators will use resting state EEG output in units of peak frequency
Treatment response
Time frame: Baseline
Treatment response defined as 50% symptom reduction as measured with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.
Treatment response
Time frame: Within 72 hours after the first treatment session
Treatment response defined as 50% symptom reduction as measured with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.
Treatment response
Time frame: Within 1 week after the last treatment session
Treatment response defined as 50% symptom reduction as measured with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.
Treatment response
Time frame: At 3-months after the last treatment session
Treatment response defined as 50% symptom reduction as measured with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.
Remission
Time frame: Baseline
with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome. Remission as measured by a score of <7.
Remission
Time frame: Within 72 hours after the first treatment session
with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome. Remission as measured by a score of <7.
Remission
Time frame: Within 1 week after the last treatment session
with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome. Remission as measured by a score of <7.
Remission
Time frame: At 3-months after the last treatment session
with the Hamilton Depression Scale (17-item version), that comprises of 17 questions on depressive symptoms measured on a scale of 0-52 points. A higher score means a worse outcome.Remission as measured by a score of <7.
10 secondary outcomes
Quality of life of patients assessed with the European Quality of Life Five Dimensions with Five Levels (Euro-QoL-5D-5L)
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Quality of life of patients assessed with the visual analog scale of the European Quality of Life Five Dimensions with Five Levels (Euro-QoL-5D-5L)
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in the global assessment of disability using the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12 item version
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in peak amplitude measured with selective attention EEG task
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in behavioral outcome measured with the selective attention EEG task
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in processing negativity measured with the selective attention EEG task
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in mismatch negativity measures (amplitude, latency and duration) obtained with the MisMatch Negativity Paradigm during an EEG recoding
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Change in subjective feeling of memory impairment on the Subjective Assessment of Memory Impairment (SAMI) questionnaire
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Change in impact of cognitive adverse events on the Subjective Assessment of Memory Impairment (SAMI) questionnaire
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Changes in the Expectation of response form
Time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Iris EC Sommer, PhD, MD principal investigator
UMC Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivastigmine Transdermal Product in people with Depressive Disorder, run by UMC Utrecht at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasper O. Nuninga, PhD (+31(6)39139525, j.o.nuninga@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of rivastigmine on scores of the verbal fluency test. (time frame: Baseline, within 72 hours after the first treatment session, within 1 week after the last treatment session and at 3-months after the last treatment session). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2024.