Background and objectives: There is evidence for ketamine use in treatment-resistant depression (TRD). Several safety and tolerability concerns arise regarding adverse drug reactions and specific subpopulations. The aim of this paper is to investigate the relationship between dissociative and psychometric measures in course of intravenous ketamine treatment in TRD inpatients with Major Depressive Disorder and Bipolar depression.
Methods: The study population of 49 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). The study may be underpowered due to the small sample size. The observations apply to 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 the diagnosis.
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
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Received 07 Feb, 2021
On 07 Feb, 2021
Received 05 Feb, 2021
Received 31 Jan, 2021
On 10 Jan, 2021
On 10 Jan, 2021
On 26 Dec, 2020
Invitations sent on 21 Dec, 2020
On 20 Dec, 2020
On 20 Dec, 2020
On 20 Dec, 2020
Posted 06 Aug, 2020
On 16 Dec, 2020
Received 15 Dec, 2020
On 09 Nov, 2020
Received 06 Oct, 2020
Received 05 Oct, 2020
On 14 Sep, 2020
Invitations sent on 11 Aug, 2020
On 11 Aug, 2020
On 04 Aug, 2020
On 16 Jul, 2020
On 15 Jul, 2020
On 13 Jul, 2020
Received 07 Feb, 2021
On 07 Feb, 2021
Received 05 Feb, 2021
Received 31 Jan, 2021
On 10 Jan, 2021
On 10 Jan, 2021
On 26 Dec, 2020
Invitations sent on 21 Dec, 2020
On 20 Dec, 2020
On 20 Dec, 2020
On 20 Dec, 2020
Posted 06 Aug, 2020
On 16 Dec, 2020
Received 15 Dec, 2020
On 09 Nov, 2020
Received 06 Oct, 2020
Received 05 Oct, 2020
On 14 Sep, 2020
Invitations sent on 11 Aug, 2020
On 11 Aug, 2020
On 04 Aug, 2020
On 16 Jul, 2020
On 15 Jul, 2020
On 13 Jul, 2020
Background and objectives: There is evidence for ketamine use in treatment-resistant depression (TRD). Several safety and tolerability concerns arise regarding adverse drug reactions and specific subpopulations. The aim of this paper is to investigate the relationship between dissociative and psychometric measures in course of intravenous ketamine treatment in TRD inpatients with Major Depressive Disorder and Bipolar depression.
Methods: The study population of 49 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). The study may be underpowered due to the small sample size. The observations apply to 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 the diagnosis.
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
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