Phase 2 Depression and Anxiety Trial, Recruiting NCT06410599 Sponsor: University Hospital Tuebingen Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT06410599
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 64 years old at the time of joining the study
  • People who have been diagnosed with long-term (chronic) depression — either recurring moderate or severe depressive episodes without full recovery between them, or a single depressive episode that has lasted two or more years
  • People whose depression has continued even after trying at least two different antidepressant medications from two different medication types
  • People whose depression has continued even after completing at least 12 sessions of talking therapy (such as psychoanalysis, depth psychology-based therapy, or cognitive behavioural therapy)
  • People who are able to understand and voluntarily sign a consent form before any study procedures begin
  • People who are able to attend all required study visits and follow the study's requirements
  • Women who could become pregnant must agree to use two reliable forms of contraception at the same time, or to avoid heterosexual contact, from the start of the study until 28 days after the last treatment
  • Men must agree to use a latex condom during any sexual contact with a woman who could become pregnant, from the first treatment until 65 days after the last treatment — this applies even after a vasectomy — and must also agree not to donate semen or sperm during that same period
  • All participants must agree not to donate blood from the first treatment until 28 days after the last treatment
  • All participants must agree not to share their study medication with anyone else

Who may not be able to join:

  • People whose primary diagnosis is a current substance misuse problem (such as drug or alcohol misuse)
  • People with certain neurological conditions such as stroke, brain tumour, brain infection, or an autoimmune brain disease
  • People with conditions that cause increased pressure inside the skull, such as from a head injury
  • People with problems with blood circulation in the brain
  • People who are pregnant or breastfeeding
  • People currently participating in another clinical study, or who have recently taken an experimental treatment that could affect this study's results
  • People who have epilepsy
  • People who have had an allergic reaction to a similar medication to the one used in this study, or to any of its ingredients
  • People who have previously been treated with ketamine hydrochloride (the study medication) or a therapy called CBASP
  • People with high blood pressure that is untreated or not well controlled (blood pressure readings above 150/100 mmHg on repeated measurement, or a lifelong diagnosis of high blood pressure)
  • People with an overactive thyroid gland that is untreated or not well controlled
  • People who have had unstable chest pain (unstable angina) or a heart attack within the last six months
  • People with raised pressure in the eye (glaucoma) or a penetrating eye injury
  • People who have had surgery or procedures in the upper airway (nose, mouth, or throat area)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Martin Walter, Prof. Dr., Universitätsklinikum Jena - Klinik für Psychiatrie und Psychotherapie

Phone: +493641 9390101

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University Hospital Tuebingen
Registry
ClinicalTrials.gov
Start date
29 April 2024
Est. completion
1 May 2026

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Change of depressive symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) between start and end of treatment in a group comparison

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov