Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02094898
Other study ID # 13-005152
Secondary ID
Status Completed
Phase Phase 2
First received March 10, 2014
Last updated August 10, 2017
Start date September 2014
Est. completion date August 2016

Study information

Verified date August 2017
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study was to find out if the medication known as ketamine could help the symptoms of depression. This drug is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent; however, it is not approved for use in depression treatment. The FDA allowed the use of this drug in this research study.


Description:

This was a single-arm, open-label trial conducted in two phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission (Montgomery Åsberg Depression Rating Scale (MÅDRS)) total score less than or equal to 9 measured 24h after any acute-phase infusion) received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.Those who responded to i.v. ketamine (less than or equal to 50% reduction from baseline in MÅDRS total score) but did not remit during acute-phase were not eligible for continuation-phase treatment. Suicidal ideation was assessed clinically throughout the trial, supplemented by scores on the MÅDRS suicide item.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of treatment.

- Ability to provide informed consent

- Male/Female

- Age 18-65 yrs.

- Major Depressive Disorder or Bipolar Disorder I or Bipolar Disorder II with Patient Health Questionnaire-9 (PHQ 9) score =15 at hospital assessment

- Treatment resistant depression (TRD) as defined by at least two previous antidepressant or mood stabilizing treatments for depression in adequate dose for 8 weeks

- Patient reported overall suicide risk score =3 on the Suicide Status Form (SSF II-R) or score of =1on Item 9 of PHQ-9 (all at admission assessment)

- Ability to pass comprehension assessment test related to effects of ketamine and trial objectives and criteria

- Voluntary admission

Exclusion Criteria:

- Diagnosis of schizophrenia, schizoaffective disorder, or active psychosis

- Index episode of depression greater than 2 years

- Ongoing prescription of =4 mg lorazepam equivalents total daily or a.m. dosing of any benzodiazepine at time of assessment

- Currently undergoing electroconvulsive therapy, deep brain stimulation or transcranial magnetic stimulation as acute series or for maintenance

- Any active or unstable medical condition as judged by principal investigator

- Previous use or abuse of methamphetamine, cocaine, stimulants (prescribed and illicit) within past 12 months

- Any current abuse or dependence of alcohol or drugs (except nicotine) and abuse or dependence of drugs and alcohol only in full remission (> 1 month, < 12 months). Patients will be allowed to enroll if their drug and alcohol abuse / dependence is in full (complete, not partial) sustained (> 1 year) remission.

- History of traumatic brain injury

- Developmental delay and intellectual disorder

- Encephalopathy (clinical diagnosis within prior 12 months of delirium)

- Cognitive disorder (mild and major)

- Previous participation in earlier Ketamine trial

- Pregnancy

- Prisoners

- Involuntarily hospitalized

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine
0.3 mg/kg/hr of ketamine infused for 100 minutes

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vande Voort JL, Morgan RJ, Kung S, Rasmussen KG, Rico J, Palmer BA, Schak KM, Tye SJ, Ritter MJ, Frye MA, Bobo WV. Continuation phase intravenous ketamine in adults with treatment-resistant depression. J Affect Disord. 2016 Dec;206:300-304. doi: 10.1016/j — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary MADRS Total Score at Baseline and Last Acute Phase Observation The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Factor 1 Score at Baseline and Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12. baseline, last acute phase observation
Secondary MADRS Factor 2 Score at Baseline and Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Factor 3 Score at Baseline and Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Factor 4 Score at Baseline and Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18. baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.) baseline, last acute phase observation (approximately 2 weeks)
Secondary MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.) baseline, last acute phase observation (approximately 2 weeks)
Secondary Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients). baseline, last acute phase observation (approximately 2 weeks)
Secondary CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients). baseline, last acute phase observation (approximately 2 weeks)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A