Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410599
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-03-05
Brief Title:
Pharmacologic Treatment Augmentation in Chronic Depression
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Pharmacologic Treatment Augmentation in Chronic Depression Randomized Controlled Double Blinded Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KetCBASP
Brief Summary:
To enroll in this clinical trial prospective participants must meet stringent criteria The participants need to fall within the age range of 18 to 64 and exhibit chronic depression at therapy resistance stage 2 This stage signifies that the participants have undergone unsuccessful treatment with at least two different antidepressants despite adequate dosage and duration Moreover the participants should have engaged in at least 12 sessions of psychotherapy without experiencing significant relief from depressive symptoms Additionally participants must demonstrate the cognitive capacity to provide informed consent
Upon expressing interest in the study and consenting to participate individuals undergo a thorough screening process This screening encompasses a comprehensive clinical interview to assess medical and psychiatric history as well as various medical tests These tests include physical examinations blood draws which may include pregnancy tests for female participants and electrocardiograms ECGs to evaluate heart function Following the screening participants are randomly assigned to one of three different treatment groups Ketamine TAU KetamineCBASP PlaceboCBASP
The study protocol involves a combination of psychotherapeutic treatment and either ketamine infusions or placebo Throughout the study period participants are subject to regular data collection including psychological assessments blood samples and magnetic resonance imaging MRI scans Participants responses to treatment as well as any changes in symptoms or side effects are closely monitored
After completing the study participants are offered follow-up therapy as part of standard care MRI scans are conducted to examine changes in brain activity associated with treatment response and depressive symptomatology particularly focusing on alterations in neural circuitry and thought processes Additionally participants are encouraged to report any changes in medication regimen or other treatments received during the study period
Upon expressing interest in the study and consenting to participate individuals undergo a thorough screening process This screening encompasses a comprehensive clinical interview to assess medical and psychiatric history as well as various medical tests These tests include physical examinations blood draws which may include pregnancy tests for female participants and electrocardiograms ECGs to evaluate heart function Following the screening participants are randomly assigned to one of three different treatment groups Ketamine TAU KetamineCBASP PlaceboCBASP
The study protocol involves a combination of psychotherapeutic treatment and either ketamine infusions or placebo Throughout the study period participants are subject to regular data collection including psychological assessments blood samples and magnetic resonance imaging MRI scans Participants responses to treatment as well as any changes in symptoms or side effects are closely monitored
After completing the study participants are offered follow-up therapy as part of standard care MRI scans are conducted to examine changes in brain activity associated with treatment response and depressive symptomatology particularly focusing on alterations in neural circuitry and thought processes Additionally participants are encouraged to report any changes in medication regimen or other treatments received during the study period
Detailed Description:
To participate in this clinical trial one must have reached the age of 18 at the time of enrollment and not have exceeded the age of 64 Additionally the pilot study is designed for patients with chronic depression who are in therapy resistance stage 2 Therapy resistance stage 2 means that one has taken at least 2 antidepressants from two different classes in sufficient dosage over a sufficient period of time without experiencing significant and sustainable improvement in depressive symptoms Furthermore one should have received at least 12 sessions of psychotherapy psychoanalysis psychodynamic psychotherapy or cognitive behavioral therapy without significant and sustainable improvement in depressive symptoms Also one must have the capacity to consent
Those interested in participating in this study must have provided written consent to participate A screening takes place to check the criteria for study participation using a clinical interview The clinical interview collects information about current and previous physical and mental symptoms or diagnoses and treatments and lasts approximately 100 minutes Additionally a physical examination a blood draw of approximately 20 ml and an electrocardiogram ECG to determine heart activity are performed
If one meets the inclusion criteria and no exclusion criteria are present one can participate in the study and will be randomly assigned to one of the three treatment groups KetamineTAU KetamineCBASP PlaceboCBASP Participants are being told what type of psychotherapy the participant will receive If one is assigned to one of the CBASP groups neither the participant nor the treatment team will be informed whether the participant is receiving ketamine or placebo
Once the group assignment is made further data is collected in the first study week In week 2 the psychotherapeutic treatment begins with a two-week introductory phase Psychotherapy includes two individual sessions per week as well as group therapies At the end of the introductory phase further data collection takes place
In week 3 additional data is collected and a blood draw is performed to repeat the pregnancy test Subsequently weeks 4-6 one is treated with an infusion twice a week for three weeks ketamine or placebo The infusions within a week are spaced 2-3 days apart and each lasts approximately 40 minutes Psychotherapy continues during these three weeks After completing the combination treatment of study medicationplacebo and psychotherapy further data is collected and psychotherapy continues for another 6 weeks weeks 7-12 After that the treatment as part of the study is completed
To optimize treatment success and prevent relapses an appropriate follow-up therapy is planned and initiated in consultation with the study therapist depending on the individual development during the study therapy Three months after completing the study therapy the final data collection is carried out Throughout the entire study a total of 9 blood draws are performed
Psychotherapy administration of study medicationplacebo and data collection are carried out at the study site Existing medication may continue to be taken during the study and will be optimized as needed If medication with benzodiazepines is prescribed it cannot be taken on the day before the infusion or on the day of the infusion
The first blood draw and urine sample are used to get an impression of ones overall health status and thus assess whether participation in the study is possible or permissible according to the inclusion and exclusion criteria In addition a drug screening is performed on the urine sample to exclude acute substance abuse alcohol drugs and a pregnancy test is performed based on the blood sample
In the event of discontinuation of the study follow-up treatment will be offered within the standard therapy for depressive disorders
Additional medications including over-the-counter ones of which the investigator is not yet aware may only be taken in emergencies after consulting the investigator If one is being treated by other doctors the other doctors must be informed about participation in the clinical trial The investigator must also be informed about any medical treatment received from another doctor during the clinical trial One will receive a study ID card which should always be carried for emergencies
The fMRI examination in weeks 3 and 12 is performed to assess changes in brain activity during treatment and in relation to changes in depressive symptoms Additionally the relationship between mind wandering and brain activity in the presence of depressive illness is analyzed
Those interested in participating in this study must have provided written consent to participate A screening takes place to check the criteria for study participation using a clinical interview The clinical interview collects information about current and previous physical and mental symptoms or diagnoses and treatments and lasts approximately 100 minutes Additionally a physical examination a blood draw of approximately 20 ml and an electrocardiogram ECG to determine heart activity are performed
If one meets the inclusion criteria and no exclusion criteria are present one can participate in the study and will be randomly assigned to one of the three treatment groups KetamineTAU KetamineCBASP PlaceboCBASP Participants are being told what type of psychotherapy the participant will receive If one is assigned to one of the CBASP groups neither the participant nor the treatment team will be informed whether the participant is receiving ketamine or placebo
Once the group assignment is made further data is collected in the first study week In week 2 the psychotherapeutic treatment begins with a two-week introductory phase Psychotherapy includes two individual sessions per week as well as group therapies At the end of the introductory phase further data collection takes place
In week 3 additional data is collected and a blood draw is performed to repeat the pregnancy test Subsequently weeks 4-6 one is treated with an infusion twice a week for three weeks ketamine or placebo The infusions within a week are spaced 2-3 days apart and each lasts approximately 40 minutes Psychotherapy continues during these three weeks After completing the combination treatment of study medicationplacebo and psychotherapy further data is collected and psychotherapy continues for another 6 weeks weeks 7-12 After that the treatment as part of the study is completed
To optimize treatment success and prevent relapses an appropriate follow-up therapy is planned and initiated in consultation with the study therapist depending on the individual development during the study therapy Three months after completing the study therapy the final data collection is carried out Throughout the entire study a total of 9 blood draws are performed
Psychotherapy administration of study medicationplacebo and data collection are carried out at the study site Existing medication may continue to be taken during the study and will be optimized as needed If medication with benzodiazepines is prescribed it cannot be taken on the day before the infusion or on the day of the infusion
The first blood draw and urine sample are used to get an impression of ones overall health status and thus assess whether participation in the study is possible or permissible according to the inclusion and exclusion criteria In addition a drug screening is performed on the urine sample to exclude acute substance abuse alcohol drugs and a pregnancy test is performed based on the blood sample
In the event of discontinuation of the study follow-up treatment will be offered within the standard therapy for depressive disorders
Additional medications including over-the-counter ones of which the investigator is not yet aware may only be taken in emergencies after consulting the investigator If one is being treated by other doctors the other doctors must be informed about participation in the clinical trial The investigator must also be informed about any medical treatment received from another doctor during the clinical trial One will receive a study ID card which should always be carried for emergencies
The fMRI examination in weeks 3 and 12 is performed to assess changes in brain activity during treatment and in relation to changes in depressive symptoms Additionally the relationship between mind wandering and brain activity in the presence of depressive illness is analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001692-37 | EUDRACT_NUMBER | None | None |