NCT04021433

Brief Summary

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 16, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

July 10, 2019

Last Update Submit

July 15, 2019

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

  • MADRS

    The change in the MDRS score at 1 month (5weeks evaluation) for the acute phase and at 6 months or end of study (for the maintenance phase) compared to baseline

    1 month into treatment through study completion

Secondary Outcomes (4)

  • MADRS

    3 months into treatment

  • QIDS-SR, Clinical Global Impressions - Improvement

    along 6 months

  • Average time in remission

    along 6 months

  • NeuroTrax computerized cognitive battery

    along 6 months

Study Arms (1)

MDD

EXPERIMENTAL

Treatment resistant patients will be treated with multiple doses of IM/SC ketamine \[dose range 0.3-1.5mg/kg\]

Drug: Ketamine

Interventions

KetamineDRUG

Repeated doses of IM/SC ketamine up to 3 times a week

MDD

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with unipolar/bipolar depression with MADRS Score\>= 20
  • Inadequate response to \>= 3 adequate treatment trials \[\>=2 trials in the present episode\]
  • If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment
  • QTc WNL

You may not qualify if:

  • Hypersensitivity to ketamine
  • Other major psychiatric diagnosis
  • High suicidality
  • Unstable physical illness
  • S/P CVA / brain SOL
  • Pregnant or breast feeding women
  • Illicit drug/alcohol abuse during last year
  • History of ketamine abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Moshe Isserles, MD

CONTACT

00972 2 6777184moshay@hadassah.org.il

Hadas Lamberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 16, 2019

Study Start

September 1, 2018

Primary Completion

October 1, 2020

Study Completion

December 30, 2020

Last Updated

July 16, 2019

Record last verified: 2019-06

Locations

IL(1)