Intravenous ketamine for Treatment Resistant... — Clinical Trial Details

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Must be ≥18 years old and meet DSM-IV-TR criteria for Major Depressive Disorder (without psychotic features) or Bipolar Disorder I or II currently in a depressive episode.
Bipolar patients must not be in a current mixed episode or have mood-incongruent psychotic features for at least 4 weeks.
Medically stable by physical exam, 12-lead ECG and laboratory tests judged not clinically significant by investigator.
HAMD-17 total score ≥17 at screening and/or day 1 (predose).
MDD patients must have failed ≥2 adequate antidepressant courses (one in current episode); recent starts allowed if minimal improvement after 4 weeks.
Dose changes of existing antidepressants require 2 weeks before screening; a 14-day washout applies for recently stopped antidepressants.
ECT permitted if ≥2 weeks since last ECT; bipolar participants must be on stable mood-stabilising medication for ≥4 weeks where applicable.
Concurrent antidepressant doses should remain stable for study duration; benzodiazepines permitted after clinician consultation.
Inpatient or outpatient willing to be admitted for IV ketamine administration and remain at site for 4 hours post-dose.
Non-insulin-dependent diabetes adequately controlled permitted.
Prior anaesthetic ketamine exposure permitted if not previously enrolled in another ketamine clinical trial.
Women of childbearing potential and heterosexually active men must use effective contraception during the study and for 1 month after last dose; negative pregnancy tests required at screening and predose.
Willing and able to adhere to protocol and provide informed consent.

Exclusion Criteria

History of drug or alcohol abuse or dependence (DSM-IV) within 6 months prior to screening, except nicotine or caffeine.
Positive drug-of-abuse screen at screening or day 1 (exceptions may apply for prescribed medications with no abuse history).
Positive repeat alcohol breath test is exclusionary.
Taking >4 psychotropic medications at day 1 (predose).
Autoimmune disorder requiring immunomodulatory therapies may be excluded per investigator judgment.
Significant cardiovascular, respiratory, neurological (including seizures), renal, hepatic, endocrine, or immunologic disease within 6 months, glaucoma, or abnormal/uncontrolled thyroid function unless stable on treatment.
Uncontrolled hypertension (diastolic >90 mmHg) at screening or day 8.
Planned vaccination within 2 weeks before first dose through 2 weeks after last dose.
Acute infection based on laboratory assessment unless investigator judges no risk.
Systemic corticosteroids within 21 days before day 1.
Known allergy, hypersensitivity or contraindication to ketamine or excipients.
Receipt of an investigational drug/device within 3 months or current participation in an investigational study.
Pregnant or breastfeeding women.
Any condition that would, in the investigator's opinion, compromise subject well-being or study participation.
Donation of ≥1 unit blood or equivalent acute blood loss within 90 days prior to dosing.
Employees or family members of the investigator or study centre with direct involvement in the study.

Company

Product

Legal

Intravenous ketamine for Treatment Resistant Depression: Exploring biomarkers of response and relapse A double-blind, randomized controlled trial

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Ketamine IV

Interventions

Placebo IV

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details