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Ketamine for Relapse Prevention in Recurrent Depressive Disorder (KINDRED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02661061
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : January 22, 2016
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Prof Declan McLoughlin, St Patrick's Hospital, Ireland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Conditions Depression
Relapse
Recurrent Depressive Disorder
Major Depressive Disorder
Interventions Drug: Ketamine
Drug: Midazolam
Enrollment 9
Recruitment Details Participants were inpatients at St Patrick's Mental Health Services admitted for treatment of an acute depressive episode with a previous history of depression
Pre-assignment Details Participants were randomised from n=28 participants in an observational phase, all of whom were receiving inpatient treatment for recurrent depressive disorder. Participants were monitored weekly for response to treatment and those who responded were invited to be randomised.
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description

Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.

Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.

Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.

Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.

Period Title: Overall Study
Started 5 4
Completed 3 2
Not Completed 2 2
Reason Not Completed
Lack of Efficacy             1             1
Withdrawal by Subject             1             1
Arm/Group Title Ketamine Midazolam Total
Hide Arm/Group Description

Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.

Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.

Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.

Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.

Total of all reporting groups
Overall Number of Baseline Participants 5 4 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  80.0%
4
 100.0%
8
  88.9%
>=65 years
1
  20.0%
0
   0.0%
1
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
Female
2
  40.0%
3
  75.0%
5
  55.6%
Male
3
  60.0%
1
  25.0%
4
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 4 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
4
 100.0%
9
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Ireland Number Analyzed 5 participants 4 participants 9 participants
5 4 9
1.Primary Outcome
Title Completion Rate for Randomised Treatment Phase
Hide Description The outcomes for this pilot trial are process outcomes, primarily rates of recruitment and retention. Thus, the completion rate for the randomised treatment phase is the primary outcome. The study is not designed to assess efficacy.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised participants who received one infusion were analysed (intention to treat)
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.

Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.

Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.

Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  60.0%
2
  50.0%
2.Secondary Outcome
Title Depression Relapse Rate During Treatment and Follow-up Phase
Hide Description Clinical outcomes are secondary in this pilot trial. The 24-item Hamilton Rating Scale for Depression (HRSD-24) was used to assess for the main clinical outcome, the relapse rate over six months. Criteria for relapse are ≥10 point increase in HRSD-24 compared to baseline score plus HRSD ≥16; in addition, increase in the HRSD should be maintained one week later (if indicated, additional follow-ups will be arranged). Hospital admission, and deliberate self-harm/suicide also constitute relapse. Relapse may also occur during the eight-week treatment phase and is captured here.
Time Frame 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description:

Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.

Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.

Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.

Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.

Overall Number of Participants Analyzed 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
2
  40.0%
3
  75.0%
Time Frame Adverse event information was collected over the entire study time frame, 29 months, from December 2015 to May 2018. Individual participants were assessed over an approximately seven-month period including their inpatient admission, eight-week randomised treatment phase, and 26-week follow-up period.
Adverse Event Reporting Description Tolerability of the trial agents was assessed at multiple points before, during and after treatment sessions using a battery of assessments used in assessing for physical and psychotomimetic side effects of ketamine (CADSS, BPRS, PRISE and YMRS), standard in the field of ketamine clinical trials for depression, as well as assessment of physical health parameters before, during and after assessments.
 
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description

Trial Interventions: participants will receive four two-weekly infusions of ketamine at 0.05mg/kg. All infusions will be administered by a consultant anaesthetist.

Ketamine: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.

Trial Interventions: participants will receive four two-weekly infusions of midazolam at 0.045mg/kg. All infusions will be administered by a consultant anaesthetist.

Midazolam: A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.

All-Cause Mortality
Ketamine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Ketamine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      1/4 (25.00%)    
Immune system disorders     
Delayed hypersensitivity reaction  1 [1]  1/5 (20.00%)  1 0/4 (0.00%)  0
Urticaria  1 [2]  0/5 (0.00%)  0 1/4 (25.00%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
[1]
Possible delayed hypersensitivity reaction a number of hours following a first ketamne infusion, consisting of rash and hypertension with no airway interference or swelling. Deemed more likely penicillin allergy. Resolved within hours, no treatment.
[2]
Pruritis and urticaria developing two days after the first midazolam infusion, other likely contributors identified (laundry detergent). Resolved with oral antihistamine.
Recruitment and randomisation rates in this pilot trial were low, leading to small participant numbers analysed. Due to the potential for breach of confidentiality, limited participant-level information has been reported.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Martha Finnegan
Organization: Trinity College Dublin
Phone: 0863638264
EMail: mfinneg@tcd.ie
Layout table for additonal information
Responsible Party: Prof Declan McLoughlin, St Patrick's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT02661061    
Other Study ID Numbers: 20/15
2015-002020-37 ( EudraCT Number )
First Submitted: December 10, 2015
First Posted: January 22, 2016
Results First Submitted: December 18, 2019
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020