NCT02659085

Brief Summary

Developing more effective and faster acting antidepressant is of outmost clinical importance. Available antidepressant therapies have a delayed therapeutic effect. It typically takes several weeks before symptom relief is evident. Furthermore, antidepressants are relatively ineffective - as many as 30% of patients do not respond to any medication at all. In this study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new antidepressant treatment for severely depressed patients and compare its effectiveness with that of electroconvulsive therapy (ECT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

4.5 years

First QC Date

December 7, 2015

Last Update Submit

December 18, 2019

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, MajorAntidepressive Agents/adverse effectsDepressive Disorder, Major/drug therapyInfusions, IntravenousKetamine/administration & dosage*Ketamine/adverse effectsTreatment OutcomeElectroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in remission in each treatment arm assessed by Montgomery-Asberg Depression Rating Scale (MADRS)

    Primary outcome is the proportion of patients in remission in each treatment arm. Remission is defined as a MADRS ≤ 10.

    Follow up of one year after treatment cessation

Secondary Outcomes (7)

  • Time to remission compared between the two treatments.

    The MADRS score is measured for a maximum of 4 weeks.

  • Time to response compared between the two treatments.

    The MADRS score is measured for a maximum of 4 weeks.

  • Ketamine treatment is associated with a smaller decrease in the performance in a CANTAB cognitive test battery compared to ECT.

    Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment.

  • Remission from severe depression is associated with improved performance in the performance in a CANTAB cognitive test battery.

    Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment.

  • The antidepressant effect of ketamine is longer lasting than that of ECT, assessed by the proportion of patients in remission (defined by a maximum score of 9 in the Montgomery-Asberg Depression Rating Scale (MADRS)).

    Within one week after remission and at three additional time points (3, 6 and 12 months) after remission

  • +2 more secondary outcomes

Study Arms (2)

Electroconvulsive Therapy (ECT)

ACTIVE COMPARATOR

ECT given in line with standard procedures (including anesthesia, muscle relaxation and oxygenation) thrice weekly. Each participating clinic decides for each patient whether the treatment is given uni- or bilateral, as well as the exact stimulation parameters. Choice of anesthetic drug (e.g. thiopental of propofol) and muscle relaxant is done by local anesthesiologist. The procedure differs in no way from how a given patient would have been treated if he or she were not included in the study.

Procedure: ECT

Ketamine IV Infusion

EXPERIMENTAL

Ketamin intra venous infusions of racemic ketamine (0.5mg/kg), delivered over a period of 40 minutes thrice weekly, as ECT (Monday, Wednesday and Friday).

Drug: Ketamine IV Infusion

Interventions

Ketamine IV InfusionDRUG

Patients randomized to the experimental treatment receive intravenous infusions of racemic ketamine (0.5 mg/kg), delivered over a period of forty minutes thrice weekly (Monday, Wednesday, Friday) under supervision.

Also known as: Ketamine
Ketamine IV Infusion
ECTPROCEDURE

ECT given in line with standard procedures (including anesthesia, muscle relaxation and oxygenation) thrice weekly.

Electroconvulsive Therapy (ECT)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-85
  • Diagnosed with major depressive disorder (MDD, according to DSM-IV)
  • Inpatients who have been offered and have accepted ECT
  • Are eligible to participate
  • Score ≥ 20 Points on Montgomery Åsberg Depression Rating Scale (MADRS)
  • Must be proficient in spoken and written Swedish
  • American Society of Anaesthesiologists physical status classification (ASA) 1-3

You may not qualify if:

  • Co-morbid conditions that could interfere with the treatment (e.g. primary psychosis)
  • Habitual difficulties to speak, hear, remember or reason
  • Treatment according to LPT (Lagen om psykiatrisk tvångsvård; Compulsory Psychiatric Care Act)
  • On-going or recent (6 months) drug abuse
  • Known allergy to the active substance
  • Pregnant or breastfeeding women
  • Known cardiovascular disease, including angina, acute/chronic congestive heart failure, moderly hypertension or tachyarrhythmia (because exacerbation by sympathomimetic properties of ketamine)
  • Pathological conditions in central nervous system with risk of increased intracranial pressure (increased ICP with ketamine)
  • Glaucoma (increased IOP with ketamine)
  • Porphyria or thyroid disorder (enhanced sympathomimetic properties by ketamine)
  • Ongoing severe infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Pouya Movahed Rad, MD, PhD

    Dept of Clinical Sciences Lund, Faculty of Medicine Lund University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 7, 2015

First Posted

January 20, 2016

Study Start

February 1, 2015

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations

SE(1)