Augmenting treatment for chronic depression with ketamine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of ketamine as an augmentation therapy for patients with chronic depression who have not responded to at least two different antidepressants and have undergone at least 12 sessions of psychotherapy. Participants aged 18 to 64 will be screened through a clinical interview, physical examination, and medical tests to ensure they meet the inclusion criteria. Those who qualify will be randomly assigned to one of three treatment groups: ketamine plus treatment as usual, ketamine plus cognitive behavioral analysis system of psychotherapy (CBASP), or a placebo group. The study seeks to determine if the combination of ketamine with psychotherapy can provide significant relief from depressive symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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
* 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)

Where it's running

• Universitätsklinikum Tübingen - Klinik für Psychiatrie und Psychotherapie
  Tübingen, Baden-Würtemberg, Germany Recruiting
• Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie
  Jena, Thuringia, Germany Recruiting

Study contacts

• Principal investigator: Martin Walter, Prof. Dr. — Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie
• Study coordinator: Martin Walter, Prof. Dr.
• Email: martin.walter@med.uni-jena.de
• Phone: +493641 9390101

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dupilumab for Major Depressive Disorder

  This study tests whether dupilumab can engage immune targets in adults with major depressive disorder to see if it can help with depressive symptoms.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07908563

• Accelerated vs Standard iTBS for Major Depression

  This trial tests whether giving more accelerated iTBS sessions is better tolerated and more effective than the standard schedule for adults with major depressive disorder.

  Recruiting Military Hospital 175 · Ho Chi Minh City · NCT07768397

• Psilocybin with Structured Integrated Reframing Therapy for trauma-related MDD and PTSD

  This trial tests whether psilocybin therapy, alone or with Structured Integrated Reframing Therapy (SIRT), helps people with trauma-related major depressive disorder who are already on a stable antidepressant.

  Recruiting Phase 3 Khyber Medical University Peshawar · Islamabad, Capital and 2 other locations · NCT07703722

• Magnesium Bisglycinate Added to Your Depression Treatment

  This study tests whether adding magnesium bisglycinate to your current antidepressant can help reduce depressive symptoms and improve sleep and daily functioning for adults with major depressive disorder.

  Recruiting All India Institute of Medical Sciences, Bhubaneswar · Bhubaneswar, Odisha · NCT07633080

• Motif XCS System for treatment-resistant depression

  This study tests whether the Motif XCS System is safe and tolerable and might help people with treatment-resistant major depressive disorder.

  Recruiting at 4 sites Motif Neurotech, Inc. · Atlanta, Georgia and 3 other locations · NCT07594483

• A Phase 3 test of DT120 for major depressive disorder

  DT120 is tested against placebo in adults with major depressive disorder to see if it can help reduce depressive symptoms.

  Recruiting at 23 sites Phase 3 Definium Therapeutics US, Inc. · Little Rock, Arkansas and 25 other locations · NCT07592689

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.