Due to slow rate of recruitment of patients with major depressive disorder in our site, it was not feasible to perform both planned Psycise studies. Therefore, all efforts were put into escitalopram study (Psycise-E).
PsyCise-S
Utility of Plasma Drug Level Monitoring and CYP2C19 Genotyping in Dose Personalization of Sertraline
Sponsor study identifier
observational
0
1 country
3
Study Start
July 16, 2020
Actual (reported)Primary Completion
September 1, 2023
Actual (reported)Study Completion
September 1, 2023
Actual (reported)The aims of this study are to:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 16, 2020
Actual (reported)December 21, 2021
Actual (reported)January 27, 2022
Actual (reported)September 1, 2023
Actual (reported)September 1, 2023
Actual (reported)Change from Baseline Depression severity score at week 8
Measured with clinician reported 21-item Hamilton rating scale for depression (HAM-D). Scale gives a score from 0 to 52 where higher score represents higher depression severity and worse outcome.
8 Weeks
Adverse drug reaction severity score at week 8
Measured with clinician reported UKU (Udvalg for Kliniske Undersogelser) side effect rating scale. Scale gives summary score from 0 to 3 where higher scores correspond to the greater side-effects severity and worse outcome.
8 Weeks
Number of participants with sertraline plasma concentrations outside the therapeutic window
at Week 2
Retrospectively determined regression formula for prediction of sertraline plasma levels at Vk based on CYP2C19 metabolizer status
8 Weeks
Change from Baseline Depression severity score at week 4
4 Weeks
Adverse drug reaction severity score at week 4
4 Weeks
Perception of stress score at baseline
Baseline
Perception of stress score at week 4
4 Weeks
Perception of stress score at week 8
8 Weeks
Patients are allocated to this group at visit V1 if 100 mg/day sertraline dose resulted in optimal sertraline exposure (20-40 ng/ml) as measured at VK. These patients continue to be treated with 100 mg/day during the V1-V2 period.
Patients are allocated to this group at visit V1 if 100 mg/day sertraline dose resulted in high (\>40 ng/ml) or low (\<20 ng/ml) sertraline exposure, as measured at VK. These patients continue to be treated with the adjusted sertraline dose, different from 100 mg/day, during the V1-V2 period.
Drug: Sertraline, a selective serotonin reuptake inhibitor (SSRI), is commercially known as Sidata® or Zoloft® in Serbia. The recommended dose for Major depressive disorder is 100 mg/day. It is recommended to start therapy with 50 mg/day, and in the case of lack of therapeutic effect dose should be increased in 50 mg increments every 2 weeks until intended pharmacological effect is reached. Dose can be increased up to the maximum dose is 200 mg/day. Sertraline is also indicated for treatment of Obsessive-compulsive disorder, Generalized anxiety disorder, Social anxiety disorder (Social phobia), Panic disorder (with or without agoraphobia) and Post-traumatic Stress Disorder by Medicines and Medical Devices Agency of Serbia. Drug levels are expected to be 50% higher in CYP2C19 poor metabolizers as compared to normal metabolizers, but no specific dosing recommendations are given by the Medicines and Medical Devices Agency of Serbia.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Study population includes outpatients suffering from Major Depressive disorder who are previously untreated, and are seeking medical help for the first time.
Clinical Centre of Serbia
Belgrade, 11000, Serbia
Institute of Mental Health
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Pennebaker JW, Susman JR. Disclosure of traumas and psychosomatic processes. Soc Sci Med. 1988;26(3):327-32. doi: 10.1016/0277-9536(88)90397-8.
Braten LS, Haslemo T, Jukic MM, Ingelman-Sundberg M, Molden E, Kringen MK. Impact of CYP2C19 genotype on sertraline exposure in 1200 Scandinavian patients. Neuropsychopharmacology. 2020 Feb;45(3):570-576. doi: 10.1038/s41386-019-0554-x. Epub 2019 Oct 24.
Two ml of plasma for the measurement of drug concentrations at visits at week 2, week 4 and week 8. Two ml of serum for biochemical analyses of liver and kidney function, cortisol levels, lipid status and glucose levels at visits at week 2, week 4 and week 8. "Buffy coat" taken from the 5 ml blood sample for DNA extraction and CYP2C19 genotyping, at any visit.
0 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2021
First Posted
January 27, 2022
Study Start
July 16, 2020
Actual (reported)Magnetic Resonance Imaging Study of Geriatric Depression
Contact the study team to confirm eligibility.
Milosavljevic F, Bukvic N, Pavlovic Z, Miljevic C, Pesic V, Molden E, Ingelman-Sundberg M, Leucht S, Jukic MM. Association of CYP2C19 and CYP2D6 Poor and Intermediate Metabolizer Status With Antidepressant and Antipsychotic Exposure: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 Mar 1;78(3):270-280. doi: 10.1001/jamapsychiatry.2020.3643.
Primary Completion
September 1, 2023
Actual (reported)Study Completion
September 1, 2023
Actual (reported)Last Updated
May 15, 2026
Record last verified: 2026-05
Individual participant data (IPD) will be shared for all parameters relevant for two primary outcomes of this study. This will include, but is not limited to IPD data on: CYP2C19 metabolizer status and CYP2C19 genotype, HAM-D scores, UKU-scale scores and measured sertraline blood concentrations.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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