Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression
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|ClinicalTrials.gov Identifier: NCT02360280|
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : December 3, 2019
Last Update Posted : May 3, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Treatment-resistant Depression||Drug: ketamine Drug: midazolam||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Intravenous Sub-anesthetic Ketamine Treatment in Treatment-Resistant Depression|
|Actual Study Start Date :||April 1, 2015|
|Actual Primary Completion Date :||October 22, 2018|
|Actual Study Completion Date :||March 19, 2019|
Experimental: Six ketamine infusions
Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.
Active Comparator: Single ketamine infusion preceded by 5 midazolam infusions
Single infusion of 0.5 mg/Kg of ketamine hydrochloride solution preceded by midazolam 0.045 mg/kg over 2 weeks.
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 12 Days of Treatment [ Time Frame: 13 days ]Average difference in the Montgomery-Asberg Depression Rating Scale (MADRS) score change between groups. The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
- Antidepressant Response Defined as >50% Decrease in MADRS Baseline Score [ Time Frame: 13 days ]Comparing the number of subjects that achieve response between groups as defined above.
- Remission Defined as MADRS Score Equal or Less Than 9 [ Time Frame: 13 days ]Comparing the number of subjects that achieve remission between groups as defined above
- Time From Post-infusion Response to Occurrence of Relapse Defined as <50% of Baseline MADRS Score [ Time Frame: 6 months ]The length of time from post-infusion response until relapse (defined as >50% of MADRS baseline score) assessed for up to 6 months.
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female Veterans aged 18 to 75 years.
- Have a telephone in their home and able to hear telephone conversations.
- Must meet current DSM-IV criteria for major depressive disorder (MDD), single or recurrent, without psychotic features confirmed by depression subset of the Structured Clinical Interview-Clinical Trial for DSM-IV (SCID).
- Have score 32 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30)for severity of major depressive episode (MDE) at screening.
- Current major depressive episode resistant to treatment defined as failure to achieve improvement from at least 2 antidepressant trials of different pharmacological classes. Systematic evaluation of previous antidepressant trials will be assessed by the Antidepressant Treatment History Form (ATHF) .
- If applicable, current antidepressant dosages including augmenting agents and/or frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study.
- Inability to speak English.
- Inability or unwillingness to provide written informed consent.
- Moderate/severe cognitive impairment by Mini Mental State Examination (MMSE) scores 27.
- Current or lifetime DSM-V criteria for post-traumatic stress disorder (PTSD), acute stress disorder, psychosis-related disorder, bipolar disorder I or II disorder, substance-induced mood disorder, any mood disorder due to a general medical condition or any Axis I disorder other than MDD as the primary presenting problem.
- History of moderate or severe traumatic brain injury, Parkinson's disease, dementia of any type, multiple sclerosis, seizures or other central nervous system (CNS) related disorders.
- History of comorbid substance disorder within 6 months of assessment plus positive urine toxicology screen test during baseline assessments.
- Clinically unstable medical illness that could compromise the patient's ability to tolerate or likely interfere with the study procedures (e.g., history of or current myocardial ischemia or arrhythmias, congestive heart failure, severe pulmonary, renal, or hepatic disease, uncontrolled hypertension).
- Current or within less than 14 days use of barbiturates or monoamine oxidase inhibitors (MAOi).
- For women: pregnancy (confirmed by lab test), initiation of female hormonal treatments within 3 months of screening, or inability/ unwillingness to use a medically accepted contraceptive method during the study.
- Imminent risk of suicidal/homicidal ideation and/or behavior with intent and/or plan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360280
|United States, Minnesota|
|Minneapolis VA Health Care System, Minneapolis, MN|
|Minneapolis, Minnesota, United States, 55417-2309|
|Principal Investigator:||Paulo R Shiroma, MD||Minneapolis VA Health Care System, Minneapolis, MN|
Documents provided by VA Office of Research and Development:
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
|First Posted:||February 10, 2015 Key Record Dates|
|Results First Posted:||December 3, 2019|
|Last Update Posted:||May 3, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Depressive Disorder, Treatment-Resistant
Depressive Disorder, Treatment-Resistant
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