Clinical TrialMajor Depressive Disorder (MDD)KetamineKetaminePlaceboCompleted

Continuation Ketamine in Major Depression

As of May 21st, 2012, the purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention strategy for patients with treatment-resistant depression (TRD) who respond to an initial series of ketamine infusions.

Target Enrollment
36 participants
Study Type
Phase I interventional
Design
Non-randomized, quadruple Blind

Detailed Description

Phase I add-on design in adults with treatment-resistant major depression. All participants receive IV ketamine 0.5 mg/kg in a repeated one-week infusion series; the continuation phase compares lithium carbonate (600–900 mg) versus placebo to evaluate relapse prevention after initial ketamine response.

ClinicalTrials.gov lists quadruple masking with non-randomised parallel assignment. Both arms include ketamine; the adjunct is lithium or placebo. Planned/actual sample size n=36; single site at Mount Sinai, New York.

Study Arms & Interventions

Ketamine + Lithium

experimental

All participants receive IV ketamine; lithium carbonate adjunct for relapse prevention.

Interventions

  • Ketamine0.5 mg/kg
    via IV• repeated over 1 week

    IV ketamine infusions

  • Compound600 - 900 mg
    via Oral• daily

    Lithium carbonate

Ketamine + Placebo

inactive

IV ketamine plus placebo capsule matching lithium.

Interventions

  • Ketamine0.5 mg/kg
    via IV• repeated over 1 week

    IV ketamine infusions

  • Placebo
    via Oral• daily

    Placebo capsule (matching lithium)

Participants

Ages
21 – 80
Sexes
Male & Female

Inclusion Criteria

  • 21–80 years; women not of childbearing potential or using a medically accepted reliable means of contraception (OC users also using a barrier); negative serum β-hCG at screening and pre-infusion; DSM-IV Major Depression without psychotic features (clinician assessment and SCID-P confirmed); history of at least one previous depressive episode (recurrent MDD) or chronic MDD (≥2 years); non-response to ≥2 adequate antidepressant trials (ATHF ≥3); IDS-C30 ≥32; current major depressive episode ≥4 weeks; capacity to consent; able to identify a family member, physician, or friend for the Treatment Contract.

Exclusion Criteria

  • Lifetime history of psychotic features, schizophrenia or other psychotic disorder, or bipolar disorder; lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome; current OCD or eating disorder (bulimia nervosa or anorexia nervosa); DSM-IV drug or alcohol abuse/dependence within the preceding 2 years; schizotypal or antisocial personality disorder, or any clinically significant Axis II disorder precluding safe participation; serious and imminent suicidal or homicidal risk; pregnant or nursing; serious, unstable medical illnesses including hepatic, renal impairment, gastroenterologic (including GERD), respiratory (including obstructive sleep apnoea or history of difficult airway), cardiovascular (including ischaemic heart disease and uncontrolled hypertension), endocrinologic, neurologic (including history of severe head injury), immunologic, or haematologic disease; clinically significant abnormal laboratory findings, physical exam, or ECG; positive urine toxicology for illicit substances at screening and within 24 hours of infusion; one or more seizures without a clear and resolved aetiology; treatment with an irreversible MAOI or any other psychotropic medication within 2 weeks prior to randomisation (except a stable dose of non-benzodiazepine hypnotics); treatment with fluoxetine within 4 weeks prior to randomisation; previous recreational use of PCP or ketamine; hypertension not controlled by diuretic or beta-blocker therapy alone or in combination (single BP >160/90 or two readings >140/90 at screening/baseline); renal impairment (BUN >20 mg/dL and/or serum creatinine >1.3 mg/dL); thyroid impairment (TSH >4.2 mU/L); cardiac disease evidenced by an ECG abnormality of concern; any anticipated change in medications that could affect fluid or salt balance (e.g., ACE inhibitor, loop diuretics, calcium channel blockers, thiazide diuretics, angiotensin II receptor blockers).

Study Details

Locations

Icahn School of Medicine at Mount Sinai — New York, New York, United States

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