Depressive Disorder, MajorPsyCise-SNCT05210153
Personalized Sertraline Dosing in Patients With Depression
An observational study of Depressive Disorder, Major, run by University of Belgrade at 3 sites in Serbia.
Trial summary
The aims of this study are to: 1. Determine the proportion of participants who are underdosed or overdosed under recommended dosing regimen of sertraline for the depression treatment (100 mg/day) 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Sertraline
- How many people
- 0 participants
- Where
- 3 sitesSerbia
- Study dates
- 16 Jul 2020to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Adult
Study population: Study population includes outpatients suffering from Major Depressive disorder who are previously untreated, and are seeking medical help for the first time.
Who may be able to join
- Diagnosed Major Depressive Disorder
- Starting monotherapy with sertraline
- Signed written informed consent
Who cannot join
- Patient's requests to leave the study
- Patients who had taken sertraline before
- Dementia
- Severe liver function impairment (abnormal AST/ALT ratio)
- Severe kidney function impairment (abnormal creatinine clearance)
- History of drug addiction (sporadic use is permitted)
Show all 9Show fewer
- Suicide risk
- Patients who are taking strong CYP2C19 inhibitors
- Severe adverse drug reaction
Trial locations and contacts
3 sites in 1 country.
Serbia3 sites
Clinical Centre of Serbia
Belgrade, 11000
Institute of Mental Health
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
About this study
Official title: Utility of Plasma Drug Level Monitoring and CYP2C19 Genotyping in Dose Personalization of Sertraline
The aims of this study are to:
- Determine the proportion of participants who are underdosed or overdosed under recommended dosing regimen of sertraline for the depression treatment (100 mg/day)
- Determine and quantify clinical benefits of personalized sertraline dosing regimen based on the sertraline blood level monitoring
- Retrospectively estimate whether the information on CYP2C19 genotype is useful in prediction of sertraline blood level.
Read the detailed description
Sertraline is an antidepressant extensively metabolized by the polymorphic CYP2C19 enzyme. Based on CYP2C19 genotype, patients can be classified as:
- Normal metabolizers (Normal CYP2C19 enzyme capacity)
- Intermediate metabolizers (Decreased CYP2C19 enzyme capacity)
- Poor metabolizers (No CYP2C19 enzyme capacity)
- Ultra rapid metabolizers (Increased CYP2C19 enzyme capacity)
Adequate sertraline exposure is needed to achieve optimal clinical response in the treatment of depression: too low drug plasma levels can lead to the lack of pharmacological effect, whereas too high drug plasma levels increases the incidence of adverse effects. There is evidence that patients with variant CYP2C19 genotypes have abnormal sertraline exposure and could benefit from sertraline dose personalization, but precise evidence-based protocol for personalized dosing of sertraline has not been developed yet. This multicentric observational clinical trial is designed to collect crucial information for the development of such protocol that will be based on drug plasma level monitoring and/or CYP2C19 genotyping.
Course of the study will be as follows:
Initial Visit (V0):
Participant will be enrolled at this point if inclusion criteria are met. Sertraline therapy will be initiated at the standard dose of 100 mg/day during next 2 weeks, or alternatively, started with 50 mg/day during first week and then increased to 100 mg/day during second week. General and socio-demographic information about the participant will be collected together with the baseline measurements: clinical questionnaires, anthropometric measurements, cardiological assessments, and the blood sample will be taken for biochemical analyses.
Mid-Visit (VK):
This visit takes place two weeks after the initial visit (V0) when sertraline blood level is expected to reach the steady state. Blood sample will be taken from the participants at the end of the dose interval (before the morning dose) for the purpose of therapeutic drug monitoring. Plasma sertraline levels will then be measured before the next visit and an independent clinician will allocate patients into one out of two cohorts based on whether or not sertraline levels were optimal (20-40 ng/ml). If sertraline levels were outside this interval, independent clinician will adjust the dose; sertraline level lower than 3 ng/ml indicates noncompliance and results in dropout, level between 3 and 10 ng/ml results in dose increase to 200 mg/day, level between 10 and 20 ng/ml results in dose increase to 150 mg/day, level between 20 and 40 ng/ml results in treatment continuation with 100 mg/day, and level higher than 40 ng/ml results in dose decrease to 50 mg/day.
Visit 1 (V1):
Visit 1 takes place two weeks after VK and 4 weeks after the initiation of the sertraline therapy. Without the knowledge of the attending clinician, independent clinician will adjust sertraline doses accordingly. Attending clinician will then assess the participants using standardized questionnaires, participants will be anthropometrically and cardiologically examined, and blood samples will be taken for the purposes of therapeutic drug monitoring and biochemical analyses.
Visit 2 (V2):
Visit 2 is the final follow-up visit and it will be done 4 weeks after the Visit 1 and 8 weeks after the sertraline initiation. All participants will be assessed for psychometrical, anthropometrical and cardiological parameters, and blood samples will be taken again for the purposes of therapeutic drug monitoring and biochemical analysis.
If needed, additional participants who are already on the stable sertraline monotherapy can be enrolled into study starting from VK. In this case, besides the blood sample for the therapeutic drug monitoring, all assessment usually done at initial visit (V0) will be performed during VK.
- Conditions
- Depressive Disorder, Major
- Being tested
- Sertraline
- Keywords
- Sertraline, Cytochrome p 450 cyp2c19, Precision medicine, Psychiatry, Pharmacogenetics, Serotonin Uptake Inhibitors
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft, Lustral
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard dose | 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. Receives: Drug: Sertraline | |
| Adjusted dose | 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. Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 Weeks
Secondary outcomes (4)
Number of participants with sertraline plasma concentrations outside the therapeutic window
Therapeutic window is defined by sertraline plasma concentrations of 20-40 ng/ml
Measured: at Week 2
Retrospectively determined regression formula for prediction of sertraline plasma levels at Vk based on CYP2C19 metabolizer status
CYP2C19 metabolizer status will be determined based on genotype as follows:
Poor metabolizer: *2/*2, *2/*3, *3/*3
Intermediate metabolizer: *1/*2, *1/*3
Normal metabolizer: *1/*1
Ultra-rapid metabolizer: *1/*17, *17/*17
Several covariates will be considered: Body mass index, Creatinine clearance, AST/ALT (Aspartate aminotransferase / Alanine aminotransferase) ratio.
Measured: 8 Weeks
Change from Baseline Depression severity score at week 4
Assessed with 21-item Hamilton rating scale for depression (HAM-D). Scale gives a score 0-52 where higher score is equivalent to the more severe depression and worse uotcome.
Measured: 4 Weeks
Adverse drug reaction severity score at week 4
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.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start16 Jul 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Centre of Serbia, Institute of Mental Health, Serbia, Military Medical Academy, Belgrade, Serbia
- Responsible party
- Principal investigator, Marin Jukic, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210153
- Sponsor's protocol ID
- 6066800-S
- Acronym
- PsyCise-S
- Status last verified
- May 2026
- First submitted
- 21 Dec 2021
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 3279521Braten 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.
PubMed 31649299Milosavljevic 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.
PubMed 33237321
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Plasma Drug Level Monitoring and CYP2C19 Genotyping in Dose Personalization of Sertraline
- ClinicalTrials.gov ID
- NCT05210153
- Acronym / sponsor ID
- PsyCise-S / 6066800-S
- Conditions
- Depressive Disorder, Major
- Keywords
- Sertraline, Cytochrome p 450 cyp2c19, Precision medicine, Psychiatry, Pharmacogenetics, Serotonin Uptake Inhibitors
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 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).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Collaborators
- Clinical Centre of Serbia, Institute of Mental Health, Serbia, Military Medical Academy, Belgrade, Serbia
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 27 Jan 2022 (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.
The aims of this study are to:
- Determine the proportion of participants who are underdosed or overdosed under recommended dosing regimen of sertraline for the depression treatment (100 mg/day)
- Determine and quantify clinical benefits of personalized sertraline dosing regimen based on the sertraline blood level monitoring
- Retrospectively estimate whether the information on CYP2C19 genotype is useful in prediction of sertraline blood level.
Detailed description
Sertraline is an antidepressant extensively metabolized by the polymorphic CYP2C19 enzyme. Based on CYP2C19 genotype, patients can be classified as:
- Normal metabolizers (Normal CYP2C19 enzyme capacity)
- Intermediate metabolizers (Decreased CYP2C19 enzyme capacity)
- Poor metabolizers (No CYP2C19 enzyme capacity)
- Ultra rapid metabolizers (Increased CYP2C19 enzyme capacity)
Adequate sertraline exposure is needed to achieve optimal clinical response in the treatment of depression: too low drug plasma levels can lead to the lack of pharmacological effect, whereas too high drug plasma levels increases the incidence of adverse effects. There is evidence that patients with variant CYP2C19 genotypes have abnormal sertraline exposure and could benefit from sertraline dose personalization, but precise evidence-based protocol for personalized dosing of sertraline has not been developed yet. This multicentric observational clinical trial is designed to collect crucial information for the development of such protocol that will be based on drug plasma level monitoring and/or CYP2C19 genotyping.
Course of the study will be as follows:
Initial Visit (V0):
Participant will be enrolled at this point if inclusion criteria are met. Sertraline therapy will be initiated at the standard dose of 100 mg/day during next 2 weeks, or alternatively, started with 50 mg/day during first week and then increased to 100 mg/day during second week. General and socio-demographic information about the participant will be collected together with the baseline measurements: clinical questionnaires, anthropometric measurements, cardiological assessments, and the blood sample will be taken for biochemical analyses.
Mid-Visit (VK):
This visit takes place two weeks after the initial visit (V0) when sertraline blood level is expected to reach the steady state. Blood sample will be taken from the participants at the end of the dose interval (before the morning dose) for the purpose of therapeutic drug monitoring. Plasma sertraline levels will then be measured before the next visit and an independent clinician will allocate patients into one out of two cohorts based on whether or not sertraline levels were optimal (20-40 ng/ml). If sertraline levels were outside this interval, independent clinician will adjust the dose; sertraline level lower than 3 ng/ml indicates noncompliance and results in dropout, level between 3 and 10 ng/ml results in dose increase to 200 mg/day, level between 10 and 20 ng/ml results in dose increase to 150 mg/day, level between 20 and 40 ng/ml results in treatment continuation with 100 mg/day, and level higher than 40 ng/ml results in dose decrease to 50 mg/day.
Visit 1 (V1):
Visit 1 takes place two weeks after VK and 4 weeks after the initiation of the sertraline therapy. Without the knowledge of the attending clinician, independent clinician will adjust sertraline doses accordingly. Attending clinician will then assess the participants using standardized questionnaires, participants will be anthropometrically and cardiologically examined, and blood samples will be taken for the purposes of therapeutic drug monitoring and biochemical analyses.
Visit 2 (V2):
Visit 2 is the final follow-up visit and it will be done 4 weeks after the Visit 1 and 8 weeks after the sertraline initiation. All participants will be assessed for psychometrical, anthropometrical and cardiological parameters, and blood samples will be taken again for the purposes of therapeutic drug monitoring and biochemical analysis.
If needed, additional participants who are already on the stable sertraline monotherapy can be enrolled into study starting from VK. In this case, besides the blood sample for the therapeutic drug monitoring, all assessment usually done at initial visit (V0) will be performed during VK.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose | – | Drug: SertralinePatients 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. |
| Adjusted dose | – | Drug: SertralinePatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Study population includes outpatients suffering from Major Depressive disorder who are previously untreated, and are seeking medical help for the first time.
Key inclusion criteria (3 listed)
- Diagnosed Major Depressive Disorder
- Starting monotherapy with sertraline
- Signed written informed consent
Key exclusion criteria (9 listed)
- Patient's requests to leave the study
- Patients who had taken sertraline before
- Dementia
- Severe liver function impairment (abnormal AST/ALT ratio)
- Severe kidney function impairment (abnormal creatinine clearance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: Zoloft, LustralDrug: 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. | Drug | Adjusted dose, Standard dose |
Primary outcome
Change from Baseline Depression severity score at week 8
Time frame: 8 Weeks
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.
Adverse drug reaction severity score at week 8
Time frame: 8 Weeks
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.
4 secondary outcomes
Number of participants with sertraline plasma concentrations outside the therapeutic window
Time frame: at Week 2
Retrospectively determined regression formula for prediction of sertraline plasma levels at Vk based on CYP2C19 metabolizer status
Time frame: 8 Weeks
Change from Baseline Depression severity score at week 4
Time frame: 4 Weeks
Adverse drug reaction severity score at week 4
Time frame: 4 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 3279521Pennebaker 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.
- Background: PubMed 31649299Braten 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.
- Background: PubMed 33237321Milosavljevic 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.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by University of Belgrade at 3 sites in Serbia.
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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Serbia. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Depression severity score at week 8 (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05210153, which also lists 3 linked publications.
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 15 May 2026.