Trial of Ketamine and Lithium Therapy in Bipolar Depression

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Chadi Abdallah, Yale University
ClinicalTrials.gov Identifier:
NCT01768767
First received: January 9, 2013
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

This study is looking at the safety and efficacy of combined ketamine and lithium therapy for treating patients with bipolar depression who are taking a mood stabilizer that is not working for them.


Condition Intervention Phase
Bipolar Depression
Drug: Placebo
Drug: Ketamine
Drug: Ketamine/Lithium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Approach of Combined Lithium-Ketamine Therapy in Bipolar Depression: To Preserve Efficacy and Minimize Adverse Effects

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 4 Hours to 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) [ Time Frame: 4 hours to 2 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Scale (CGI) [ Time Frame: 4 hours to 2 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: 4 hours to 2 weeks ] [ Designated as safety issue: Yes ]
  • Brief Psychotic Rating Scale (BPRS) [ Time Frame: 1 and 4 hours ] [ Designated as safety issue: Yes ]
  • Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: 1 and 4 hours ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2013
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine/Lithium
Participant will receive ketamine/lithium
Drug: Ketamine/Lithium
Active Comparator: Ketamine
Participant will receive ketamine
Drug: Ketamine
Placebo Comparator: Placebo
Participant will receive placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between the ages of 18-65 years. Females will be included if they are not pregnant and agreed to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy) or if post-menopausal for at least 1 year, or surgically sterile.
  • Able to provide written informed consent according to Yale HIC guidelines.
  • Bipolar Disorder in Major Depressive Episode (296.5x or 296.89), as determined by the Structured Clinical Interview for DSM-IV (SCID) patient edition 80
  • Montgomery Asberg Depression Rating Scale (MADRS) score of 18 or higher.
  • Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR16) score of 19 or higher.
  • Be able to understand and speak English.

Exclusion Criteria:

  • Patients with a history of DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression.
  • Patients with current hypomanic and/or manic symptoms meeting DSM-IV-TR criteria of mixed episode are excluded.
  • DSM IV-TR Axis I disorders are excluded if they are considered primary disorders.
  • Dementia or suspicion thereof, is also exclusionary.
  • Serious suicide or homicide risk, as assessed by evaluating clinician; A serious suicide risk will be considered an inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death.
  • Substance abuse or dependence during the 3 months prior to screening.
  • History of serious medical or neurological illness.
  • Signs of major medical or neurological illness on examination or as a result of a 12 lead ECG screening or laboratory studies.
  • Abnormality on physical examination. A subject with a clinical abnormality may be included only if the study physician considers the abnormality will not introduce additional risk factors and will not interfere with the study procedure.
  • Positive urine drug screen.
  • Pregnant or lactating women or a positive urine pregnancy test; for women of childbearing potential.
  • Subjects who test positive for HIV or viral hepatitis (hepatitis B and/or C) will be excluded as a means to (1) protect the subjects and research staff from the increased risks of blood borne pathogen transmission during placebo/ketamine infusions and (2) to minimize the factors which might influence the biochemical responses and affect the study outcome. This test will take place at the screening visit. Subjects will be invited back to the Yale Depression Research Program, either for their next study visit or for a HIV/Hep debriefing session. HIV results will be given in a face to face meeting no matter what the results are.
  • Patients requiring excluded medications (see Table 3 for details).
  • History indicating learning disability or mental retardation.
  • Known sensitivity to ketamine or lithium.
  • Resting blood pressure lower than 90/60 or higher than 150/90,or resting heart rate lower than 50/min or higher than 100/min.
  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: NCT01768767

Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Chadi Abdallah, MD Yale University
  More Information

No publications provided

Responsible Party: Chadi Abdallah, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01768767     History of Changes
Other Study ID Numbers: 1209010758
Study First Received: January 9, 2013
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Ketamine
Lithium
Lithium Carbonate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Antimanic Agents

ClinicalTrials.gov processed this record on September 18, 2014