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History of Changes for Study: NCT00947791
Treatment Study of Bipolar Depression
Latest version (submitted April 11, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 27, 2009 None (earliest Version on record)
2 March 10, 2011 Recruitment Status, Study Status, Sponsor/Collaborators, Study Identification, Contacts/Locations, Study Design and References
3 September 14, 2012 Sponsor/Collaborators and Study Status
4 April 11, 2017 Study Status, Sponsor/Collaborators, Arms and Interventions, Study Identification, Oversight, Study Design, Results and Study Description
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Study NCT00947791
Submitted Date:  July 27, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: 08-1422
Brief Title: Treatment Study of Bipolar Depression
Official Title: INTRAVENOUS KETAMINE IN TREATMENT-RESISTANT BIPOLAR DEPRESSION
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2009
Overall Status: Recruiting
Study Start: July 2009
Primary Completion: July 2011 [Anticipated]
Study Completion: July 2011 [Anticipated]
First Submitted: July 27, 2009
First Submitted that
Met QC Criteria:
July 27, 2009
First Posted: July 28, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 27, 2009
Last Update Posted: July 28, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Icahn School of Medicine at Mount Sinai
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Depression
Treatment-Resistant
ketamine
antidepressant
glutamate
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 12 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Ketamine Drug: Midazolam
participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg
Placebo Comparator: Midazolam Drug: midazolam
participants in this group/condition receive a single IV infusion of midazolam, 0.025 mg/kg
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Montgomery-Asberg Depression Rating Scale (MADRS)
[ Time Frame: 24 hrs post-infusion compared to baseline ]

Secondary Outcome Measures:
1. Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
[ Time Frame: 24 hrs post-infusion compared to baseline ]

2. Young Mania Rating Scale (YMRS)
[ Time Frame: 24 hrs post-infusion compared to baseline ]

3. Brief Psychiatric Rating Scale (BPRS)
[ Time Frame: 4 hrs post-infusion compared to baseline ]

4. Clinician-Administered Dissociative States Scale (CADSS)
[ Time Frame: 4 hrs post-infusion compared to baseline ]

5. Systematic Assessment for Treatment Emergent Effects (SAFTEE)
[ Time Frame: 4 hrs post-infusion compared to baseline ]

Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 (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.
Open or close this module Contacts/Locations
Study Officials: James W Murrough, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Locations: United States, New York
Mount Sinai School of Medicine
[Recruiting]
New York, New York, United States, 10029
Contact:Contact: James W Murrough, MD 212-241-6383 james.murrough@mssm.edu
Contact:Principal Investigator: James W Murrough, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Paterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. PubMed 10987815
Links:
Available IPD/Information:

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