Mood Disorder; OpioidNCT05985811
Ketamine Enhances Analgesia and Mood in Chronic Pain Patients
An observational study of Mood Disorder; Opioid and Mood Insomnia, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorder; Opioid, Mood Insomnia
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 2 Feb 2018to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult chronic pain clinic patients who have mood disorders; and undergoing routine regular ketamine injections for pain therapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, V3S 7J1
Olumuyiwa Bamgbade, MD, FRCPC, +17786286600, salem.painclinic@gmail.com
About this study
Official title: Ketamine Analgesia Enhances Functional Quality and Mood in Chronic Pain Patients
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.
Read the detailed description
Chronic pain is usually associated with psychological and mood disorders. Many chronic pain patients have various forms of mood abnormalities; and these mood issues may improve with better analgesia produced by Ketamine injections.
This is a prospective observational study of consenting adult patients who are undergoing interventional pain management. The patients undergo routine interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected using validated tools. Data collection includes patients' age, psychiatric diagnosis, pain score, sleep score, anxiety score and depression score.
Pain score is measured using the numeric pain rating scale, and a change in the pain score by 2-points is considered significant. Sleep score is measured using the Likert sleep scale, and a change in the sleep score by 2-points is considered significant. Anxiety is measured using the general anxiety disorder (GAD-7) scale, and a change in the anxiety score by 4-points is considered significant. Depression is measured using the patient health questionnaire (PHQ-9) scale, and a change in the depression score by 5-points is considered significant.
Data is analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.
- Conditions
- Mood Disorder; Opioid, Mood Insomnia
- Keywords
- Mood therapy
- Medical subject headings
- Mood Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
Sleep quality score, objective measurement using the validated Likert sleep scale
Sleep quality score, using the Likert sleep scale of 0 to 10, low scores indicate poor sleep, high scores indicate better sleep
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start2 Feb 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood Disorder; OpioidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olumuyiwa Bamgbade, MD,FRCPC, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985811
- Sponsor's protocol ID
- SalemAnes2018 Ketamine Mood
- Status last verified
- Jan 2025
- First submitted
- 2 Aug 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Analgesia Enhances Functional Quality and Mood in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT05985811
- Acronym / sponsor ID
- SalemAnes2018 Ketamine Mood
- Conditions
- Mood Disorder; Opioid, Mood Insomnia
- Keywords
- Mood therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic pain is usually associated with psychological and mood disorders. Many chronic pain patients have various forms of mood abnormalities; and these mood issues may improve with better analgesia produced by Ketamine injections.
This is a prospective observational study of consenting adult patients who are undergoing interventional pain management. The patients undergo routine interventional pain therapy using Ketamine injections. Pre-injection and post-injection patient data is collected using validated tools. Data collection includes patients' age, psychiatric diagnosis, pain score, sleep score, anxiety score and depression score.
Pain score is measured using the numeric pain rating scale, and a change in the pain score by 2-points is considered significant. Sleep score is measured using the Likert sleep scale, and a change in the sleep score by 2-points is considered significant. Anxiety is measured using the general anxiety disorder (GAD-7) scale, and a change in the anxiety score by 4-points is considered significant. Depression is measured using the patient health questionnaire (PHQ-9) scale, and a change in the depression score by 5-points is considered significant.
Data is analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult chronic pain clinic patients who have mood disorders; and undergoing routine regular ketamine injections for pain therapy.
Key inclusion criteria (6 listed)
- adult chronic pain patients
- associated mood disorder
- good treatment compliance
- associated chronic insomnia
- regular ketamine pain therapy injection
Key exclusion criteria (8 listed)
- severe cognitive disorder
- inability to provide consent
- major neuropsychiatric disorder
- cannabis use
- stimulant use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain score, objective measurement using the validated Numeric Pain Rating scale
Time frame: 12 weeks
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
1 secondary outcome
Sleep quality score, objective measurement using the validated Likert sleep scale
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olumuyiwa Bamgbade, MD,FRCPC principal investigator
Salem Anaesthesia Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorder; Opioid and Mood Insomnia, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olumuyiwa Bamgbade, MD,FRCPC (17786286600, salem.painclinic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score, objective measurement using the validated Numeric Pain Rating scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.