Anxiety DisordersPhase 1NCT06065735

Concentration-QT Study of Paroxetine in Healthy Adults

A Phase 1 study testing Paroxetine in people with Anxiety Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Anxiety Disorders
What is being tested?: Paroxetine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited Kingdom
Study dates: 2 Oct 2023to 8 Jan 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants, both male and female, aged between 18 to 65 years, at the time of signing the informed consent.
Participants determined as healthy based on medical evaluation by an experienced physician.
A female participant is eligible to participate if she is of:
Nonchildbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
Child-bearing potential and agrees to use one of the contraception methods for an appropriate time as mentioned in the study protocol.
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase, and bilirubin ≤ 1.5x (Upper Limit of Normal) ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

Show all 16Show fewer

Body weight ≥ 45 kilogram (kg) and Body Mass Index (BMI) within the range 18 to 29.5 kilogram per metre square (kg/m2) (inclusive).
No significant abnormality on 12-lead Electrocardiogram (ECG) at Screening in supine position, including the following specific requirements:
Heart rate ≥ 40 beats per minute
PR interval ≤ 220 milliseconds (msec) (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used)
Q waves < 50 msec (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used)
QRS interval to be ≥ 60msec and < 120msec (For PR, QRS and QTcF interval, and Q wave, the mean of triplicate ECGs will be used)
The waveforms must enable the QT interval to be clearly defined
QTcF interval must be < 450msec (machine or manual reading).
A signed and dated written informed consent obtained from participants capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked) or light smokers (less than 5 cigarettes per day).

Who cannot join

History or presence of any medically significant disease that may cause additional risk or interfere with the study procedures or outcome.
History of symptomatic arrhythmias.
History of hypersensitivity to paroxetine and excipients
History of abnormal coagulation parameters, bleeding disorders or conditions which may predispose to bleeding.
History of, or active suicidal ideation. Includes assessment using the Columbia Suicide Severity Rating Scale (C-SSRS)
Must not have a pre-diagnosed mood disorder

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Participant is mentally or legally incapacitated.
A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHG) at Screening.
A supine heart rate outside the range 50-90 beats per minute (bpm) at Screening.
A positive screening Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
A positive drug/alcohol screen at screening or prior to dosing.
A positive test for Human Immune Virus (HIV) antibody at Screening.
History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 millilitre [ml]) of beer, 1 glass (125ml) of wine or 1 (25 ml) measure of spirits.
The participant has participated in a clinical trial and has received an investigational product within the following time prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Use of the following medications within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of the study medication: monoamine oxidase inhibitors (including linezolid), thioridazine, pimozide, serotonergic drugs (including L-tryptophan, triptans, tramadol, selective serotonin reuptake inhibitors, lithium and fentanyl, tamoxifen, anti-coagulants, clozapine, phenothiazines, tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, Cox-2 inhibitors, antiarrhythmics, quinolone antibiotics, macrolides (including clarithromycin and erythromycin), ketoconazole and itraconazole
Use of non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
No current use of any medication other than paracetamol (doses ≤2 grams/day).
Consumption of Seville oranges, pummelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
Where participation in the study would result in donation of blood or blood products more than 500 mL within a 3-month period.
Pregnant females as determined by positive serum β-HCG test at screening or serum/ urine beta-Human chorionic gonadotropin (HCG) prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Participants with unsuitable veins for cannulation and repeat venepuncture.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
London, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: An Open-Label, Single Arm, Dose Escalating Concentration-QT Study to Investigate the Cardiac Effects and Safety of Paroxetine in Healthy Adult Participants

The primary purpose of the study is to evaluate the potential effect of paroxetine on QTc interval following escalating doses in healthy participants. Participants with no history of cardiac abnormalities or mood disorders will be enrolled. During the study, participants will take paroxetine at three incremental dose levels. Participants will attend the clinic at screening, baseline, at the end of each dose level administration week, and a final study exit visit. While on treatment outside of clinic visits, participants will be followed-up via video-call. A concentration-QTc analysis will assess any potential correlation between paroxetine plasma concentration and QTc prolongation. In addition, the occurrence of any side-effects will be compared between on and off treatment.

Conditions: Anxiety Disorders
Being tested: Paroxetine
Keywords: Dose escalation, QTc Interval, Paroxetine, Healthy Adults
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ParoxetineDrug
Paroxetine will be administered

Study groups in NCT06065735
Study group	Role	What they receive
Paroxetine	Experimental	Not described Receives: Drug: Paroxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value.
Measured: Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1

Secondary outcomes (7)

Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in the supine position using a semi-automatic blood pressure recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and standard deviation (SD) values of vital sign assessments at Day 48 are reported.
Measured: Baseline (Day -1) and Day 48
Change From Baseline in Vital Sign: Pulse Rate
Pulse rate was measured in the supine position using a semi-automatic recording device with an appropriate cuff size after at least 5 minutes of rest. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.
Measured: Baseline (Day -1) and Day 48
Change From Baseline in Vital Sign: Body Temperature
Body temperature measurements were performed in participants. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value. Mean and SD values of vital sign assessments at Day 48 are reported.
Measured: Baseline (Day -1) and Day 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or any other situation as determined per medical and scientific judgment.
Measured: Up to Day 48
Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters
The laboratory measurements included hematology, clinical chemistry and coagulation parameters. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets, Reticulocytes, Alanine Aminotransferase, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Potassium, Sodium, Creatinine kinase, Prothrombin time (PT), activated partial thromboplastin time (aPTT), international normalized ration (INR). Clinical significance was determined by the investigator. Number of participants with clinically significant findings in hematology, clinical chemistry and coagulation were reported.
Measured: Up to Day 48
Number of Participants With Clinically Significant Findings for Vital Signs
Vital signs included systolic and diastolic blood pressure, pulse rate and body temperature. Blood pressure and pulse rate were measured with the participant in supine position after at least 5 minutes rest. Clinical significance was determined by the investigator. Number of participants with clinically significant findings in vital signs were reported.
Measured: Up to Day 48
Number of Participants With Clinically Significant Findings for Physical Examinations
Physical examinations included assessment of skin, lungs, cardiovascular system, and abdomen (liver and spleen). Clinical significance was determined by the investigator. Number of Participants with clinically significant findings for physical examinations were reported.
Measured: Up to Day 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 20238 Jan 2024

First posted4 Oct 2023
Study start2 Oct 2023
Primary completion8 Jan 2024
Study completion8 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06065735
Sponsor's protocol ID: 219882
Status last verified: Jul 2026
First submitted: 26 Sep 2023
Last updated: 19 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Publications

van Dijkman SC, Felices M, Pandurangavittal B, Ghorpade S, Easterbrook C, Zabielski M, Della Pasqua O. An open-label, single-arm, dose-escalating concentration-QT study to investigate the cardiac effects and safety of paroxetine in healthy adults. Br J Clin Pharmacol. 2026 May;92(5):1385-1396. doi: 10.1002/bcp.70398. Epub 2026 Jan 14.
PubMed 41535245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single Arm, Dose Escalating Concentration-QT Study to Investigate the Cardiac Effects and Safety of Paroxetine in Healthy Adult Participants
ClinicalTrials.gov ID: NCT06065735
Acronym / sponsor ID: 219882
Conditions: Anxiety Disorders
Keywords: Dose escalation, QTc Interval, Paroxetine, Healthy Adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 2 Oct 2023 (actual)
Primary completion: 8 Jan 2024 (actual)
Study completion: 8 Jan 2024 (actual)
First posted: 4 Oct 2023 (actual)
Results: Posted 16 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Paroxetine	Experimental	Drug: Paroxetine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Participants, both male and female, aged between 18 to 65 years, at the time of signing the informed consent.
Participants determined as healthy based on medical evaluation by an experienced physician.
A female participant is eligible to participate if she is of:
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase, and bilirubin ≤ 1.5x (Upper Limit of Normal) ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Body weight ≥ 45 kilogram (kg) and Body Mass Index (BMI) within the range 18 to 29.5 kilogram per metre square (kg/m2) (inclusive).

Key exclusion criteria (25 listed)

History or presence of any medically significant disease that may cause additional risk or interfere with the study procedures or outcome.
History of symptomatic arrhythmias.
History of hypersensitivity to paroxetine and excipients
History of abnormal coagulation parameters, bleeding disorders or conditions which may predispose to bleeding.
History of, or active suicidal ideation. Includes assessment using the Columbia Suicide Severity Rating Scale (C-SSRS)

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
ParoxetineParoxetine will be administered	Drug	Paroxetine

Primary outcome

Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)
Time frame: Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1
A standard 12-lead electrocardiogram (ECG) were recorded in a participant using an ECG machine after 10 minutes rest in the supine position. Baseline was defined as the sample obtained on Day -1. Change from Baseline was calculated by subtracting Baseline value from post dose value.

7 secondary outcomes

Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline (Day -1) and Day 48
Change From Baseline in Vital Sign: Pulse Rate
Time frame: Baseline (Day -1) and Day 48
Change From Baseline in Vital Sign: Body Temperature
Time frame: Baseline (Day -1) and Day 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 48
Number of Participants With Clinically Significant Findings for Hematology, Clinical Chemistry and Coagulation Laboratory Parameters
Time frame: Up to Day 48
Number of Participants With Clinically Significant Findings for Vital Signs
Time frame: Up to Day 48
Number of Participants With Clinically Significant Findings for Physical Examinations
Time frame: Up to Day 48

Results and safety

Results posted to the registry on 16 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Who Received Paroxetine 20 mg	38	33
Participants Who Received Paroxetine 40 mg	0	0
Participants Who Received Paroxetine 60 mg	0	0

Primary outcome: Change From Baseline in Corrected QT Interval by Fridericia (QTcF Interval)

Time frame: Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1. Mean (Standard Deviation). Unit: Milliseconds

Measure	Participants Who Received Paroxetine 20 mg n = 33	Participants Who Received Paroxetine 40 mg n = 32	Participants Who Received Paroxetine 60 mg n = 31
0.25 Hours Pre-dose on Day 1	1.9 (7.37)	1.0 (10.82)	0.9 (9.88)
1 Hour Post-dose on Day 1	2.2 (10.68)	2.9 (12.60)	0.6 (13.35)
2 Hours Post-dose on Day 1	-3.0 (9.54)	-2.9 (10.83)	-4.2 (11.05)
3 Hours Post-dose on Day 1	-7.1 (8.48)	-5.4 (10.10)	-6.9 (8.92)
4 Hours Post-dose on Day 1	-4.4 (9.68)	-4.2 (10.48)	-4.6 (10.70)
4.5 Hours Post-dose on Day 1	-2.5 (8.26)	-1.2 (11.85)	-1.5 (11.15)
5 Hours Post-dose on Day 1	-0.3 (10.08)	0.9 (12.53)	-0.7 (10.37)
5.5 Hours Post-dose on Day 1	4.0 (8.49)	3.6 (11.91)	3.2 (10.57)

Population analysed: Pharmacodynamic Population included all participants in the Safety Population who had at least 1 non-missing ECG assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality, serious adverse events (SAEs) and common (>=3%) non-serious adverse events (Non-SAEs) were collected up to Day 48. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Who Received Paroxetine 20 mg	1 of 38 (2.6%)	23 of 38 (60.5%)	0 of 38
Participants Who Received Paroxetine 40 mg	0 of 33 (0%)	19 of 33 (57.6%)	0 of 33
Participants Who Received Paroxetine 60 mg	0 of 32 (0%)	9 of 32 (28.1%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 41535245van Dijkman SC, Felices M, Pandurangavittal B, Ghorpade S, Easterbrook C, Zabielski M, Della Pasqua O. An open-label, single-arm, dose-escalating concentration-QT study to investigate the cardiac effects and safety of paroxetine in healthy adults. Br J Clin Pharmacol. 2026 May;92(5):1385-1396. doi: 10.1002/bcp.70398. Epub 2026 Jan 14.
Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

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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.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paroxetine in people with Anxiety Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.

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 16 inclusion and 25 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: finished, as of the sponsor's last update on 19 Aug 2026. 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 United Kingdom. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Corrected QT Interval by Fridericia (QTcF Interval) (time frame: Baseline (Day -1); 0.25 Hours Pre-dose on Day 1; 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12 Hours Post-dose on Day 1). 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 NCT06065735, which also lists 1 linked publication.

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 19 Aug 2026.