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Treatment Study of Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947791
Recruitment Status : Terminated (Change in available resources for study procedures)
First Posted : July 28, 2009
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE July 27, 2009
First Posted Date  ICMJE July 28, 2009
Results First Submitted Date  ICMJE April 11, 2017
Results First Posted Date  ICMJE May 17, 2017
Last Update Posted Date May 17, 2017
Study Start Date  ICMJE July 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hrs post-infusion compared to baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
  • Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) [ Time Frame: 24 hrs post-infusion compared to baseline ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: 24 hrs post-infusion compared to baseline ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 4 hrs post-infusion compared to baseline ]
  • Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: 4 hrs post-infusion compared to baseline ]
  • Systematic Assessment for Treatment Emergent Effects (SAFTEE) [ Time Frame: 4 hrs post-infusion compared to baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Study of Bipolar Depression
Official Title  ICMJE Intravenous Ketamine in Treatment-Resistant Bipolar Depression
Brief Summary The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.
Detailed Description Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with this devastating condition. Despite the high degree of morbidity and mortality associated with bipolar depression, currently available treatments are few and often inadequate. Recently, a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine has demonstrated rapid antidepressant effects in severe unipolar depression. Therefore, the objective of the current study is to investigate the safety and efficacy of a single IV dose of ketamine in treatment-resistant bipolar depression (TRBD).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Patient, doctor and rater are masked (triple masked). Only the research pharmacist is unblinded.
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: ketamine
    a single IV infusion of ketamine, IV 0.5 mg/kg
  • Drug: midazolam
    a single IV infusion of midazolam, 0.045 mg/kg
Study Arms  ICMJE
  • Experimental: Ketamine/Midazolam
    Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to ketamine-midazolam. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart.
    Interventions:
    • Drug: ketamine
    • Drug: midazolam
  • Experimental: Midazolam/Ketamine
    Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to midazolam-ketamine. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart.
    Interventions:
    • Drug: ketamine
    • Drug: midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 10, 2011)
1
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2009)
12
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (see above for definition for adequate trials);
  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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947791
Other Study ID Numbers  ICMJE GCO 08-1422
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party James Murrough, Icahn School of Medicine at Mount Sinai
Original Responsible Party James W. Murrough, M.D., Mount Sinai School of Medicine
Current Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James W Murrough, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP