Clinical TrialTreatment-Resistant Depression (TRD)KetamineCompleted

Oral Aspirin + Ketamine as Adjunct to Oral Antidepressant Therapy for Depression

Open-label, single-group proof-of-concept study (n=15 actual) assessing simultaneous administration of oral aspirin (486 mg) + oral ketamine (80 mg) as an adjunct to oral antidepressant therapy in outpatients with treatment-resistant depression.

Target Enrollment
15 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

Prospective open-label, single-group proof-of-concept trial evaluating a proprietary VTS-K formulation (486 mg aspirin + 80 mg ketamine) given as a partially buccal/partially swallowed oral dose to adults with treatment-resistant depression.

Participants attend three visits: two in-person dosing/observation visits (at least two hours observation each) and one remote follow-up. Primary outcome is change in depressive symptoms; safety monitored via vital signs and adverse events.

Study population: medically stable adults (18–89 years) with unipolar treatment-resistant major depressive disorder (MADRS >22) who have failed at least one adequate antidepressant trial.

Study Protocol

Preparation

sessions

Dosing

2 sessions
120 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

VTS-K

experimental

Proprietary oral formulation of aspirin (486 mg) and ketamine (80 mg) administered as a partially buccal/partially swallowed formulation.

Interventions

  • Ketamine80 mg
    via Oral• two sessions• 2 doses total

    Per-dose contains 486 mg aspirin + 80 mg ketamine (VTS-K).

Participants

Ages
18 – 89
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Adult patients with Treatment Resistant Depression with Montgomery-Asberg Depression Rating Scale score >22 upon presentation to the clinic
  • Treatment Resistant Depression is defined as Major Depressive Disorder that does not cease after at least 6 week trial of another class of antidepressants
  • Unipolar Depression

Exclusion Criteria

  • Exclusion Criteria:
  • Adult patients with recent or current suicidal ideation with an intent to act, homicidal ideations with an intent to act
  • History of Bipolar Disorder, Obsessive Compulsive Disorder, antisocial personality disorder, borderline personality disorder, and congestive cardiac failure
  • Uncontrolled hypertension (BP >140 mm Hg systolic and/or >90 mm Hg diastolic on two separate readings at the time of screening) or on 2 medications for hypertension
  • Patients with unstable vital signs (systolic blood pressure <90 or >160 mm Hg, pulse rate <50 or >150 beats/min, and respiration rate <10 or >30 breaths/min)
  • History of Gastrointestinal hemorrhage, renal and hepatic insufficiency
  • Allergy to Ketamine or Aspirin
  • Active Substance Abuse Disorder
  • Active psychosis
  • Active Peptic Ulcer Disease
  • Lithium Therapy
  • Swallowing difficulty
  • Consumption of Aspirin or NSAID's within 6 hours of arrival to the site
  • Previous participation in this study; a patient may not re-enroll in another study while in this study
  • Pregnant or breastfeeding

Study Details

Locations

Maimonides Medical Center — Brooklyn, New York, United States

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