Ketamine for relapse prevention in recurrent depressive disorder: a randomised,controlled pilot trial

Phase 1

• Conditions: Recurrent depressive disorder; MedDRA version: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-002020-37-IE
• Lead Sponsor: St Patrick's Mental Health Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-04
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Patients =18 years with DSM-V criteria for recurrent depressive disorder (RDD), a 24-item Hamilton Rating Scale
for Depression (HRSD-24) score of =21, and voluntarily admitted to SPUH for treatment of the acute depressive
episode will be invited to participate. The DSM-V criteria for RDD are =2 previous depressive episodes with at
least 2-months (consecutive) subthreshold or no symptoms in between. (The inclusion criterion for this trial was amended on 15.9.16 and the enriched criterion of >3 episodes of depression has been removed). HRSD-24 will be repeated on a weekly basis for the duration of the
inpatient stay. Upon meeting response criteria, patients will be invited to take part in the randomised controlled
pilot trial. They will be assessed by physical examination, routine haematology and biochemistry investigations,
and an ECG to screen for any medical conditions that might affect ability to be treated with ketamine.
For the randomised pilot trial, RDD patients must have (i) received antidepressant treatment for the
acute depressive episode, whether pharmacological, psychotherapeutic or multidisciplinary, (ii) achieved at least
response criteria (i.e. =60% decrease from baseline HRSD-24 score and score =16), (iii) have a nominated adult
who can stay with them for 24-hours on out-patient treatment days, (iv) have a Mini-Mental State Examination
(MMSE) score of =24, and (v) be able to provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Current involuntary admission, any condition rendering patients medically unfit for ketamine or midazolam;
active suicidal intention; dementia; lifetime history of bipolar disorder, post-traumatic stress disorder, or Axis 1
diagnosis other than RDD; ECT for treatment of the index depressive episode; alcohol/substance abuse in
previous six-months; pregnancy or inability to confirm use of adequate contraception during the trial;
inability/refusal to consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified