Major Depressive DisorderPhase 2Ket+CBASPNCT06410599
Pharmacologic Treatment Augmentation in Chronic Depression
A Phase 2 study testing Ketamine, CBASP and TAU in people with Major Depressive Disorder, run by University Hospital Tuebingen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Ketamine, CBASP and TAU
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- 29 Apr 2024to Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 64 years at the time of study inclusion.
- Diagnosis of chronic depression: recurrent depressive disorder, severe or moderate episodes (no full remission between the episodes according to DSM-IV-TR (Falkai et al., 2015) [no distinct depressive symptoms for at least two months]) or acute depressive episode lasting two or more years
- Treatment resistance stage 2 according to (Thase and Rush, 1997): Patient's symptoms fulfil the criteria of chronic depression listed above even after at least two appropriate treatment attempts with two antidepressant medicaments from two different effect categories
- Patient's symptoms fulfil the criteria of chronic depression listed above even after executing at least 12 sessions of psychotherapeutic treatment (psychoanalysis, depth psychology-based psychotherapy or cognitive behaviour therapy)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/ procedures.
- Able to adhere to the study visit schedule and other protocol requirements.
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- Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact from study start until 28 days after the last infusion.
- Males must agree to use a latex condom during any sexual contact with FCBP from the first infusion until 65 days after the last infusion, even if the person has undergone a successful vasectomy to refrain from donating semen or sperm from the first infusion until 65 days after the last infusion.
- All subjects must agree to refrain from donating blood from the first infusion until 28 days after last infusion.
- All subjects must agree not to share medication.
Who cannot join
- Acute substance misuse as primary diagnosis (assessed by the Structured Clinical Interview for DSM-V (SKID, Wittchen et al., 1997))
- Neurologic disorders: Stroke, cerebral ischemia, tumor, cerebral infection, autoimmune disease (according to clinical interview)
- Disorders with increase of intracranial pressure, e. g. due to head injury (according to clinical interview)
- Circulatory disturbance in the brain (according to clinical interview)
- Pregnant or lactating females
- Participation in any clinical study or having taken any investigational therapy, which would interfere with the study's primary end point
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- Epilepsy (according to clinical interview)
- History of hypersensitivity to an investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product (according to clinical interview)
- Pre-treatment with ketamine hydrochloride (Ketamin Inresa 2 ml) and/ or - CBASP (according to clinical interview)
- Not or insufficiently treated hypertonia (subject will be excluded if repeated measures (3 times/ day) show values greater than 150 mmHg systolic or 100 mmHg diastolic blood pressure or if a lifetime diagnosis of hypertonia is reported)
- Not or insufficiently treated hyperthyroidism (according to clinical interview)
- Heartache due to insufficient blood circulation (unstable angina pectoris) or heart muscle infarct (myocardia infarct) during the last six months (according to clinical interview)
- Increased intraocular pressure (glaucoma) and perforating eye injury (according to clinical interview)
- Interventions in the area of the upper respiratory passages (according to clinical interview)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie
Jena, Thuringia, 07743
Martin Walter, Prof. Dr., +49 36419390101, martin.walter@med.uni-jena.de
Alexander Refisch, Dr., +4936419390451, Alexander.Refisch@med.uni-jena.de
- Recruiting
Universitätsklinikum Tübingen - Klinik für Psychiatrie und Psychotherapie
Tübingen, Baden-Würtemberg, 72070
Andreas J Fallgatter, Prof. Dr., +4970712984858, andreas.fallgatter@med.uni-tuebingen.de
Martin Walter, Prof. Dr., +4936419390101, martin.walter@med.uni-jena.de
About this study
Official title: Pharmacologic Treatment Augmentation in Chronic Depression "Randomized, Controlled, Double Blinded, Phase II Study"
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; Ketamine+CBASP, Placebo+CBASP).
Read more
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.
Read the 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 (Ketamine+TAU; Ketamine+CBASP, Placebo+CBASP). 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 medication/placebo 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 medication/placebo, 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 one's 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Ketamine, Placebo, CBASP, TAU
- Keywords
- Ketamine, CBASP, Augmentation, Combination therapy, Chronic depression, MDD
- 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.
KetamineDrug
Also called Ketamine hydrochloride (Ketamin Inresa 2 ml)
Two ketamine hydrochloride (Ketamin Inresa 2 ml) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Ketamine hydrochloride (Ketamin Inresa 2 ml) is applied continuously over a time span of 40 minutes with a subanesthetic dosage of 0.5 mg per kg body weight.
PlaceboDrug
Also called Saline solution: Fresenius Kabi Deutschland GmbH Isotone E NaCL 0.9 %
Two times placebo (Isotone E NaCL 0.9 %) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Placebo is applied continuously over a time span of 40 minutes.
CBASPBehavioural
Also called Cognitive Behavioral Analysis System of Psychotherapy
In addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific.
TAUBehavioural
Also called Treatment as usual
Standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine+TAU | Experimental | Combination of ketamine hydrochloride (Ketamin Inresa 2 ml) and TAU during week 4 to 6.
TAU (treatment as usual): standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements. Receives: Drug: Ketamine; Behavioral: TAU |
| Placebo+CBASP | Placebo comparator | Combination of placebo and CBASP during week 4 to 6.
CBASP: In addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific. Receives: Drug: Placebo; Behavioral: CBASP |
| Ketamine+CBASP | Experimental | Combination of ketamine hydrochloride (Ketamin Inresa 2 ml) and CBASP during week 4 to 6.
CBASP: In addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific. Receives: Drug: Ketamine; Behavioral: CBASP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of depressive symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) between start and end of treatment in a group comparison
Change of depressive symptoms (assessed with Montgomery-Åsberg Depression Rating Scale (MADRS), Schmidtke et al., 1988) between start of and six weeks after end of combination treatment (Δ t1-t3) in group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus TAU). Lower scores indicate better treatment outcome.
Measured: 3 months after enrollment
Secondary outcomes (2)
Change of depressive symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) in a group comparison
Change of depressive Symptoms (assessed with Montgomery-Åsberg Depression Rating Scale (MADRS), Schmidtke et al., 1988) between start of combination treatment and three months after the end of study treatment (Δ t1- follow up). Lower scores indicate better treatment outcome.
Measured: 6 months after enrollment
Change of depressive symptoms of self-reported depressive symptoms (assessed with Beck-Depression-Inventory (BDI) in a group comparison
Change of self-reported depressive symptoms assessed with Beck-Depression-Inventory (BDI), Beck et al., 2001) between start of and six weeks after end of combination treatment (Δ t1-t3) in group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus treatment as usual (TAU). Lower scores indicate better treatment outcome.
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start29 Apr 2024
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Mental Health
- Responsible party
- Sponsor
- Investigators
- Martin Walter, Prof. Dr., Principal investigator, Universitätsklinikum Jena - Klinik für Psychiatrie und PsychotherapieAndreas J Fallgatter, Prof. Dr., Principal investigator, Universitätsklinikum Tübingen - Klinik für Psychiatrie und Psychotherapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410599
- Sponsor's protocol ID
- 519/2019AMG1
- Other IDs
- 2019-001692-37, 2019
- Acronym
- Ket+CBASP
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2024
- Last updated
- 27 Mar 2025
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Treatment Augmentation in Chronic Depression "Randomized, Controlled, Double Blinded, Phase II Study"
- ClinicalTrials.gov ID
- NCT06410599
- Acronym / sponsor ID
- Ket+CBASP / 519/2019AMG1
- Conditions
- Major Depressive Disorder
- Keywords
- Ketamine, CBASP, Augmentation, Combination therapy, Chronic depression, MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Center for Mental Health
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 May 2024 (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.
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; Ketamine+CBASP, Placebo+CBASP).
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 (Ketamine+TAU; Ketamine+CBASP, Placebo+CBASP). 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 medication/placebo 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 medication/placebo, 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 one's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine+TAU | Experimental | Drug: Ketamine, Behavioral: TAUCombination of ketamine hydrochloride (Ketamin Inresa 2 ml) and TAU during week 4 to 6. TAU (treatment as usual): standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements. |
| Placebo+CBASP | Placebo comparator | Drug: Placebo, Behavioral: CBASPCombination of placebo and CBASP during week 4 to 6. CBASP: In addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific. |
| Ketamine+CBASP | Experimental | Drug: Ketamine, Behavioral: CBASPCombination of ketamine hydrochloride (Ketamin Inresa 2 ml) and CBASP during week 4 to 6. CBASP: In addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age: 18 to 64 years at the time of study inclusion.
- Diagnosis of chronic depression: recurrent depressive disorder, severe or moderate episodes (no full remission between the episodes according to DSM-IV-TR (Falkai et al., 2015) [no distinct depressive symptoms for at least two months]) or acute depressive episode lasting two or more years
- Treatment resistance stage 2 according to (Thase and Rush, 1997): Patient's symptoms fulfil the criteria of chronic depression listed above even after at least two appropriate treatment attempts with two antidepressant medicaments from two different effect categories
- Patient's symptoms fulfil the criteria of chronic depression listed above even after executing at least 12 sessions of psychotherapeutic treatment (psychoanalysis, depth psychology-based psychotherapy or cognitive behaviour therapy)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/ procedures.
Key exclusion criteria (14 listed)
- Acute substance misuse as primary diagnosis (assessed by the Structured Clinical Interview for DSM-V (SKID, Wittchen et al., 1997))
- Neurologic disorders: Stroke, cerebral ischemia, tumor, cerebral infection, autoimmune disease (according to clinical interview)
- Disorders with increase of intracranial pressure, e. g. due to head injury (according to clinical interview)
- Circulatory disturbance in the brain (according to clinical interview)
- Pregnant or lactating females
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 |
|---|---|---|
| KetamineAlso: Ketamine hydrochloride (Ketamin Inresa 2 ml)Two ketamine hydrochloride (Ketamin Inresa 2 ml) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Ketamine hydrochloride (Ketamin Inresa 2 ml) is applied continuously over a time span of 40 minutes with a subanesthetic dosage of 0.5 mg per kg body weight. | Drug | Ketamine+CBASP, Ketamine+TAU |
| PlaceboAlso: Saline solution: Fresenius Kabi Deutschland GmbH Isotone E NaCL 0.9 %Two times placebo (Isotone E NaCL 0.9 %) infusions (interval 2-3 days) per week for three weeks, 6 infusions in total. Placebo is applied continuously over a time span of 40 minutes. | Drug | Placebo+CBASP |
| CBASPAlso: Cognitive Behavioral Analysis System of PsychotherapyIn addition to standard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements, patients in the CBASP conditions receive one CBASP group session (50 min) per week for 12 weeks. The single sessions (one 50 min and one 25 min per week) contents are CBASP-specific. | Behavioural | Ketamine+CBASP, Placebo+CBASP |
| TAUAlso: Treatment as usualStandard ward psychotherapeutic program (group and single sessions) with cognitive behavioural, sociotherapeutic, occupational therapy and physiotherapeutic elements. | Behavioural | Ketamine+TAU |
Primary outcome
Change of depressive symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) between start and end of treatment in a group comparison
Time frame: 3 months after enrollment
Change of depressive symptoms (assessed with Montgomery-Åsberg Depression Rating Scale (MADRS), Schmidtke et al., 1988) between start of and six weeks after end of combination treatment (Δ t1-t3) in group 1 (ketamine plus CBASP) vs. group 2 (placebo plus CBASP) and in group 1 vs. group 3 (ketamine plus TAU). Lower scores indicate better treatment outcome.
2 secondary outcomes
Change of depressive symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) in a group comparison
Time frame: 6 months after enrollment
Change of depressive symptoms of self-reported depressive symptoms (assessed with Beck-Depression-Inventory (BDI) in a group comparison
Time frame: 3 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Martin Walter, Prof. Dr. principal investigator
Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie
Andreas J Fallgatter, Prof. Dr. principal investigator
Universitätsklinikum Tübingen - Klinik für Psychiatrie und Psychotherapie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine, CBASP and TAU in people with Major Depressive Disorder, run by University Hospital Tuebingen at 2 sites in Germany.
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 10 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Walter, Prof. Dr. (+493641 9390101, martin.walter@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of depressive symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) between start and end of treatment in a group comparison (time frame: 3 months after enrollment). 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 27 Mar 2025.