Clinical TrialBipolar DisorderKetamineKetamineTerminated

Treatment Study of Bipolar Depression

Randomised, double-blind crossover study (n=1 actual) comparing a single IV ketamine infusion (0.5 mg/kg) with single IV midazolam (0.045 mg/kg) for acute treatment of bipolar depression.

Target Enrollment
1 participants
Study Type
Phase IV interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, crossover, treatment trial in patients with treatment-resistant bipolar I or II depression evaluating safety and efficacy of a single IV ketamine infusion (0.5 mg/kg) versus active comparator midazolam (0.045 mg/kg) given two weeks apart.

Primary objectives are rapid antidepressant efficacy and safety; key inclusion requires IDS-C30 ≥32 and prior failure of at least three adequate pharmacotherapy trials; participants maintained on divalproex ER and off other psychotropics per protocol.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine/Midazolam

experimental

Crossover sequence: ketamine infusion and midazolam infusion 2 weeks apart; patients randomised to sequence ketamine→midazolam.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    Single IV infusion of ketamine 0.5 mg/kg.

  • Compound0.045 mg/kg
    via IV• single dose

    Single IV infusion of midazolam 0.045 mg/kg (active comparator).

Midazolam/Ketamine

experimental

Crossover sequence: midazolam infusion then ketamine infusion 2 weeks apart; patients randomised to sequence midazolam→ketamine.

Interventions

  • Compound0.045 mg/kg
    via IV• single dose

    Single IV infusion of midazolam 0.045 mg/kg (active comparator).

  • Ketamine0.5 mg/kg
    via IV• single dose

    Single IV infusion of ketamine 0.5 mg/kg.

Participants

Ages
21 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Male or female patients, 21-70 years;
  • 2. Primary diagnosis of bipolar I or II disorder as assessed by the SCID-P and confirmed by a study psychiatrist;
  • 3. Current depressive episode ≥ 8 weeks duration;
  • 4. History of a failure to respond to at least three (3) adequate pharmacotherapy trials in the current depressive episode;
  • 5. Subjects must be on a stable dose of divalproex ER with serum levels greater than 55 mcg/ml prior to enrollment;
  • 6. Subjects must be free of psychotropic medication for at least 2 weeks (4 weeks for fluoxetine) prior to enrollment (with the exception of divalproex ER as above);
  • 7. Subjects must have scored ≥ 32 on the IDS-C30 at both Screening and Infusion Day #1 and #2;

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Women who plan to become pregnant, are pregnant or are breast-feeding;
  • 2. Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
  • 3. Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
  • 4. Lifetime history of schizophrenia, schizoaffective disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
  • 5. Current presence of psychotic, mixed or manic symptoms;
  • 6. Lifetime history of antidepressant-induced switch to a manic episode;
  • 7. History of rapid cycling bipolar subtype;
  • 8. Drug or alcohol abuse within the preceding 3 months or dependence within the preceding 5 years;
  • 9. Lifetime exposure to ketamine or phencyclidine;
  • 10. Patients judged by study investigator to be at high risk for suicide.

Study Details

  • Status
    Terminated
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment1 participants
  • Timeline
    Start: 2009-07-01
    End: 2009-10-01
  • Compounds
    KetamineKetamine
  • Topic
    Bipolar Disorder

Locations

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

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