Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboKetamineActive not recruiting

Pharmacologic treatment augmentation in chronic depression randomised, controlled, double-blinded, Phase II study

Randomised, double-blinded, placebo-controlled Phase II trial (n=60) testing intravenous ketamine (Ketamin Inresa) with CBASP versus placebo+CBASP and ketamine+treatment-as-usual for chronic, treatment-resistant depression in Germany.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Multi-arm, randomised, double-blinded Phase II study evaluating whether adding intravenous ketamine to CBASP leads to greater reduction in depressive symptoms versus placebo plus CBASP and versus ketamine plus treatment as usual.

Primary outcome is change in MADRS from baseline to six weeks after end of combination treatment; secondary outcomes include longer-term MADRS changes and self-reported BDI scores up to three months follow-up.

Active product: Ketamin Inresa (intravenous infusion). Placebo comparator: 0.9% NaCl infusion. CBASP is delivered as structured psychotherapy for relevant arms.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Ketamine + CBASP

experimental

Intravenous ketamine (Ketamin Inresa) combined with structured CBASP psychotherapy.

Interventions

  • Ketamine
    via IV• per protocol

    Ketamin Inresa 2 ml intravenous infusion; dose and schedule per protocol; combined with CBASP psychotherapy.

Placebo + CBASP

inactive

Intravenous placebo (0.9% NaCl) combined with CBASP psychotherapy.

Interventions

  • Placebo
    via IV• per protocol

    Fresenius Kabi 0.9% NaCl infusion as placebo; combined with CBASP psychotherapy.

Ketamine + TAU

experimental

Intravenous ketamine with treatment as usual (no CBASP group therapy).

Interventions

  • Ketamine
    via IV• per protocol

    Ketamin Inresa 2 ml intravenous infusion; participants receive treatment as usual rather than CBASP.

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Age 18–64 years.
  • Diagnosis of chronic depression (recurrent depressive disorder, moderate or severe episodes with no full remission between episodes, or an acute depressive episode lasting ≥2 years).
  • Treatment-resistant stage 2 (at least two adequate antidepressant trials from two different classes) or insufficient response after ≥12 sessions of psychotherapeutic treatment.
  • Ability to understand and voluntarily sign informed consent and to comply with protocol and visit schedule.
  • Contraception: males must use condoms during heterosexual contact from first infusion until 65 days after last infusion and must not donate semen; females of childbearing potential must use two reliable forms of contraception simultaneously or practice complete abstinence from study start until 28 days after last infusion.

Exclusion Criteria

  • Acute substance misuse as primary diagnosis.
  • Neurologic disorders (stroke, cerebral ischaemia, tumour, cerebral infection, autoimmune neurological disease).
  • Conditions increasing intracranial pressure or circulatory disturbances of the brain.
  • Pregnancy or lactation.
  • Participation in another clinical study or receipt of investigational therapy that would interfere with the primary end point.
  • Epilepsy.
  • Known hypersensitivity to the investigational medicinal products or excipients.
  • Prior pretreatment with ketamine hydrochloride and/or CBASP.
  • Uncontrolled arterial hypertension (resting systolic/diastolic >150/100 mmHg).
  • Untreated hyperthyroidism.
  • Unstable angina pectoris or myocardial infarction within the last six months.
  • Increased intraocular pressure (glaucoma) or perforating eye injury.
  • Recent interventions in the area of the upper respiratory passages.

Study Details

Locations

Germany

Your Library