Pharmacologic Treatment Augmentation in Chronic Depression

Launched by UNIVERSITY HOSPITAL TUEBINGEN · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new treatment options for adults aged 18 to 64 who have chronic depression that hasn't improved despite trying at least two different antidepressants and undergoing psychotherapy. The goal is to see if adding ketamine, a medication known for its rapid effects on mood, to standard therapy can help improve symptoms of major depressive disorder. Participants will be carefully screened to ensure they meet the criteria, and those who qualify will be randomly assigned to receive either ketamine with therapy, a placebo (inactive treatment) with therapy, or ketamine with a specific type of psychotherapy called CBASP.

If you or a loved one is interested in participating, you'll go through a thorough screening process that includes medical interviews and tests to ensure safety. Throughout the trial, your symptoms will be closely monitored, and you'll have regular check-ins to assess how the treatment is working. After the study, participants will receive follow-up therapy as part of their care. It's important to know that there are specific requirements for participation, such as using reliable contraception if you are a woman of childbearing age, and there are certain health conditions that could exclude someone from joining the trial.

Gender

ALL

Eligibility criteria

• 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)