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Treatment Study of Bipolar Depression

This study has been terminated.
(Change in available resources for study procedures)
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Murrough, James, M.D.
ClinicalTrials.gov Identifier:
NCT00947791
First received: July 27, 2009
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Bipolar Disorder
 Drug: Midazolam
Drug: midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: INTRAVENOUS KETAMINE IN TREATMENT-RESISTANT BIPOLAR DEPRESSION

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Murrough, James, M.D.:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hrs post-infusion compared to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) [ Time Frame: 24 hrs post-infusion compared to baseline ] [ Designated as safety issue: No ]
  • Young Mania Rating Scale (YMRS) [ Time Frame: 24 hrs post-infusion compared to baseline ] [ Designated as safety issue: Yes ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 4 hrs post-infusion compared to baseline ] [ Designated as safety issue: Yes ]
  • Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: 4 hrs post-infusion compared to baseline ] [ Designated as safety issue: Yes ]
  • Systematic Assessment for Treatment Emergent Effects (SAFTEE) [ Time Frame: 4 hrs post-infusion compared to baseline ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947791

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Murrough, James, M.D.
Mount Sinai School of Medicine
Investigators
Principal Investigator: James W Murrough, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Murrough, James, M.D.
ClinicalTrials.gov Identifier: NCT00947791     History of Changes
Other Study ID Numbers: 08-1422
Study First Received: July 27, 2009
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Murrough, James, M.D.:
Bipolar Disorder
Depression
Treatment-Resistant
 ketamine
antidepressant
glutamate

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Midazolam
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 16, 2013