Ketamine for Relapse Prevention in Recurrent Depressive Disorder

NCT02661061 | Terminated Phase 1 Results DMC

• 2 other identifiers: 20/152015-002020-37
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for depression relapse prevention in persons at high risk. The main purpose of the pilot study is to assess trial processes to help inform a future definitive trial.

Conditions

Depression; Relapse; Recurrent Depressive Disorder; Major Depressive Disorder

Keywords

ketamine; glutamate; relapse prevention

Outcome Measures

Primary Outcomes (1)

• Completion Rate for Randomised Treatment Phase

  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.

  2 years

Secondary Outcomes (1)

• Depression Relapse Rate During Treatment and Follow-up Phase

  8 months

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Drug: Ketamine

Midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

Ketamine DRUG

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

Also known as: Ketalar

Ketamine

Midazolam DRUG

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

Also known as: Hypnovel

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Hamilton Rating Scale for Depression, 24-item (HRSD-24) score of ≥21
• Voluntary admission for treatment of acute depressive episode
• Meet DSM-IV criteria for recurrent depressive disorder (RDD): ≥2 previous depressive episodes with at least 2-months(consecutive) subthreshold or no symptoms in between PLUS(to enrich the sample for those at high risk for relapse) must also have experienced ≥3 major depressive episodes(including index episode) within the previous 2 years
• For the randomised pilot trial, RDD patients must have:
• received antidepressant treatment for the acute depressive episode(pharmacological, psychotherapeutic or multidisciplinary)
• ≥60% decrease from baseline HRSD-24 score and score ≤16
• Standardised Mini-Mental State Examination (sMMSE) score of ≥24
• able to provide informed consent

You may not qualify if:

• Current involuntary admission
• Medical condition rendering unfit for ketamine/midazolam
• Active suicidal intention
• Dementia
• History of Axis 1 diagnosis other than RDD
• Electroconvulsive therapy (ECT) for treatment of current depressive episode
• Alcohol/substance abuse in previous six months
• Pregnancy or inability to confirm use of adequate contraception during the trial

Sponsors & Collaborators

• St Patrick's Hospital, Ireland: lead

Study Sites (1)

St Patrick's University Hospital

Dublin, 8, Ireland

Location

MeSH Terms

Conditions

Depression; Recurrence; Depressive Disorder; Depressive Disorder, Major

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr Martha Finnegan
• Organization: Trinity College Dublin

mfinneg@tcd.ie

0863638264

Study Officials

• Declan McLoughlin

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking took place by sealed envelope random allocation and double blinding of participants and raters was assessed throughout. The anaesthesiologist administering infusions was aware of the allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomised, double-blind, placebo-controlled study designed to assess feasibility of recruitment, randomisation and retention.

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: January 22, 2016
• Study Start: December 1, 2015
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)