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Research article
Adam Włodarczyk
Gdanski Uniwersytet Medyczny
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8549-254X
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background and objectives: There is evidence for ketamine use in treatment-resistant depression (TRD). Several safety concerns arise regarding adverse drug reactions and specific subpopulations. The aim of this paper is to investigate the safety of intravenous ketamine treatment concerning dissociative and psychotic measures in TRD inpatients with Major Depressive Disorder (MDD) and Bipolar depression (BP) with somatic comorbidities.
Methods: The study population of forty-nine inpatients comprises of MDD and BP subjects treated with ketamine registered in the naturalistic observational protocol of the tertiary reference unit for mood disorders (NCT04226963). This dataset represents an intermittent analysis of an observational study performed for interim modelling of observational learning. The study may be underpowered due to the small sample size. The observations apply to the inhomogeneous TRD population in a single-site with no blinding and are limited to the acute administration.
Results: The epilepsy was significantly associated with changes in BPRS over time (p=0.008). Psychotic symptomatology with BPRS scores for comorbid somatic conditions excluding epilepsy turned out to be insignificant (p = 0.198) regardless of the diagnosis. However, for a subgroup of patients with epilepsy substantial fluctuation was seen across all administrations in the time course of the study.
Conclusions: In ketamine use, careful consideration of comorbidities and concomitant medication is needed. In ketamine administration, close-clinical supervision is necessary at every visit. Psychotic symptoms must be taken into consideration in planning treatment with TRD patients with epilepsy. Somatic comorbidity may impact dissociative symptomatology.
Trial Registration: Study registered: 04DEC2019, clinicaltrials.com no. NCT04226963 https://clinicaltrials.gov/ct2/show/NCT04226963
Keywords
ketamine, treatment resistant depression, dissociation, psychosis, comorbidity, safety
This is a list of supplementary files associated with this preprint. Click to download.
- Additionalfile1.pdf
Table 4. Antiepileptic treatment in patients with epilepsy.
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CURRENT STATUS: Under Review
Version 2
Posted 07 Jan, 2021
No community comments so far
Review #3 received
Received 07 Feb, 2021
Editorial decision: Major revision
On 07 Feb, 2021
Review #1 received
Received 05 Feb, 2021
Review #2 received
Received 31 Jan, 2021
Reviewer #3 agreed
On 10 Jan, 2021
Reviewer #2 agreed
On 10 Jan, 2021
Reviewer #1 agreed
On 26 Dec, 2020
Reviewers invited
Invitations sent on 21 Dec, 2020
Editor assigned
On 20 Dec, 2020
Submission checks complete
On 20 Dec, 2020
Editor invited
On 20 Dec, 2020
No comments provided
Editorial decision: Major revision
On 16 Dec, 2020
Review #3 received
Received 15 Dec, 2020
Reviewer #3 agreed
On 09 Nov, 2020
Review #2 received
Received 06 Oct, 2020
Review #1 received
Received 05 Oct, 2020
Reviewer #2 agreed
On 14 Sep, 2020
Reviewers invited
Invitations sent on 11 Aug, 2020
Reviewer #1 agreed
On 11 Aug, 2020
Editor invited
On 04 Aug, 2020
Editor assigned
On 16 Jul, 2020
Submission checks complete
On 15 Jul, 2020
First submitted
On 13 Jul, 2020
Metrics
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PDF Downloads: ...
HTML Views: ...
Subject Areas
Psychiatry
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This preprint is under consideration at BMC Psychiatry. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Adam Włodarczyk
Gdanski Uniwersytet Medyczny
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8549-254X
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 2
Posted 07 Jan, 2021
No community comments so far
Review #3 received
Received 07 Feb, 2021
Editorial decision: Major revision
On 07 Feb, 2021
Review #1 received
Received 05 Feb, 2021
Review #2 received
Received 31 Jan, 2021
Reviewer #3 agreed
On 10 Jan, 2021
Reviewer #2 agreed
On 10 Jan, 2021
Reviewer #1 agreed
On 26 Dec, 2020
Reviewers invited
Invitations sent on 21 Dec, 2020
Editor assigned
On 20 Dec, 2020
Submission checks complete
On 20 Dec, 2020
Editor invited
On 20 Dec, 2020
No comments provided
Editorial decision: Major revision
On 16 Dec, 2020
Review #3 received
Received 15 Dec, 2020
Reviewer #3 agreed
On 09 Nov, 2020
Review #2 received
Received 06 Oct, 2020
Review #1 received
Received 05 Oct, 2020
Reviewer #2 agreed
On 14 Sep, 2020
Reviewers invited
Invitations sent on 11 Aug, 2020
Reviewer #1 agreed
On 11 Aug, 2020
Editor invited
On 04 Aug, 2020
Editor assigned
On 16 Jul, 2020
Submission checks complete
On 15 Jul, 2020
First submitted
On 13 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Psychiatry
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background and objectives: There is evidence for ketamine use in treatment-resistant depression (TRD). Several safety concerns arise regarding adverse drug reactions and specific subpopulations. The aim of this paper is to investigate the safety of intravenous ketamine treatment concerning dissociative and psychotic measures in TRD inpatients with Major Depressive Disorder (MDD) and Bipolar depression (BP) with somatic comorbidities.
Methods: The study population of forty-nine inpatients comprises of MDD and BP subjects treated with ketamine registered in the naturalistic observational protocol of the tertiary reference unit for mood disorders (NCT04226963). This dataset represents an intermittent analysis of an observational study performed for interim modelling of observational learning. The study may be underpowered due to the small sample size. The observations apply to the inhomogeneous TRD population in a single-site with no blinding and are limited to the acute administration.
Results: The epilepsy was significantly associated with changes in BPRS over time (p=0.008). Psychotic symptomatology with BPRS scores for comorbid somatic conditions excluding epilepsy turned out to be insignificant (p = 0.198) regardless of the diagnosis. However, for a subgroup of patients with epilepsy substantial fluctuation was seen across all administrations in the time course of the study.
Conclusions: In ketamine use, careful consideration of comorbidities and concomitant medication is needed. In ketamine administration, close-clinical supervision is necessary at every visit. Psychotic symptoms must be taken into consideration in planning treatment with TRD patients with epilepsy. Somatic comorbidity may impact dissociative symptomatology.
Trial Registration: Study registered: 04DEC2019, clinicaltrials.com no. NCT04226963 https://clinicaltrials.gov/ct2/show/NCT04226963
This is a list of supplementary files associated with this preprint. Click to download.
- Additionalfile1.pdf
Table 4. Antiepileptic treatment in patients with epilepsy.
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