NCT05985811

Brief Summary

Most chronic pain patients have mood disorders. The mood disorders may improve with better analgesia produced by Ketamine injections. A prospective study of patients undergoing interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected. Pain is measured using numeric pain rating scale, and change in pain score by 2-points is considered significant. Sleep is measured using Likert sleep scale, and change in sleep score by 2-points is considered significant. Anxiety is measured using general anxiety disorder (GAD-7) scale, and change in anxiety score by 4-points is considered significant. Depression is measured using patient health questionnaire (PHQ-9), and change in depression score by 5-points is considered significant.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 2, 2018

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

7.9 years

First QC Date

August 2, 2023

Last Update Submit

January 23, 2025

Conditions

Keywords

Mood therapy

Outcome Measures

Primary Outcomes (1)

  • Pain score, objective measurement using the validated Numeric Pain Rating scale

    Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

    12 weeks

Secondary Outcomes (1)

  • Sleep quality score, objective measurement using the validated Likert sleep scale

    12 weeks

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult chronic pain clinic patients who have mood disorders; and undergoing routine regular ketamine injections for pain therapy.

You may qualify if:

  • adult chronic pain patients
  • associated mood disorder
  • good treatment compliance
  • associated chronic insomnia
  • regular ketamine pain therapy injection
  • consent for clinical record quality assurance review

You may not qualify if:

  • severe cognitive disorder
  • inability to provide consent
  • major neuropsychiatric disorder
  • cannabis use
  • stimulant use
  • substance abuse
  • poor treatment compliance
  • lack of ketamine pain therapy injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

RECRUITING

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Olumuyiwa Bamgbade, MD,FRCPC

    Salem Anaesthesia Pain Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olumuyiwa Bamgbade, MD,FRCPC

CONTACT

Olu Bamgbade, MD,FRCPC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

February 2, 2018

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations