Clinical TrialMajor Depressive Disorder (MDD)KetamineUnknown status

Study of Ketamine as an Antidepressant in Major Depressive Disorder

Single-group, Phase I–II study (n=35) evaluating a single IV ketamine infusion (0.5 mg/kg over 40 minutes) with four-hour monitoring in adults with major depressive disorder.

Target Enrollment
35 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

Open single-group treatment study administering a single IV infusion of ketamine hydrochloride 0.5 mg/kg over 40 minutes with four hours of post-infusion monitoring.

Primary outcomes assess changes in neuroimaging and biochemical measures; secondary outcomes include depressive and manic symptoms, global psychiatric change, and suicidal ideation.

Study Protocol

Preparation

0 sessions

Dosing

1 sessions
240 min each

Integration

0 sessions

Study Arms & Interventions

Ketamine infusion

experimental

Single IV infusion of ketamine hydrochloride 0.5 mg/kg over 40 minutes with four hours monitoring.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    0.5 mg/kg infused over 40 minutes; 4-hour monitoring post-infusion.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria: Male patients, ages 18 to 65 years with a diagnosis of MDD, currently depressed or in a current major depressive episode of BD without psychotic features will be recruited into this substudy.
  • Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.

Exclusion Criteria

  • Exclusion Criteria: Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using other antidepressant drugs in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.
  • Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  • Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
  • Clinically significant abnormal laboratory tests.
  • Subjects with clinical hypothyroidism or hyperthyroidism.
  • Subjects with one or more seizures without a clear and resolved etiology.
  • Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).

Study Details

  • Status
    Unknown status
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment35 participants
  • Timeline
    Start: 2012-01-02
    End: 2013-01-02
  • Compound
    Ketamine
  • Topic
    Major Depressive Disorder (MDD)

Locations

The PLA 102nd Hospital and mental health center of military — Changzhou, Jiangsu, China

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