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Treatment Study of Bipolar Depression

This study has been terminated.
(Change in available resources for study procedures)
Sponsor:
Information provided by (Responsible Party):
James Murrough, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT00947791
First received: July 27, 2009
Last updated: April 11, 2017
Last verified: April 2017
  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 Phase
Bipolar Disorder
Drug: ketamine
Drug: midazolam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Masking Description:
Patient, doctor and rater are masked (triple masked). Only the research pharmacist is unblinded.
Primary Purpose: Treatment
Official Title: Intravenous Ketamine in Treatment-Resistant Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hrs post-infusion compared to baseline ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: James W Murrough, MD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: James Murrough, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00947791     History of Changes
Other Study ID Numbers: GCO 08-1422
Study First Received: July 27, 2009
Results First Received: April 11, 2017
Last Updated: April 11, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Bipolar Disorder
Depression
Treatment-Resistant
ketamine
antidepressant
glutamate

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

ClinicalTrials.gov processed this record on May 22, 2017