Trial · NCT00605865
Drug Use Investigation of Jzoloft.
NCT00605865, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-10-01
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ConductScience Library. Drug Use Investigation of Jzoloft. Trials, record NCT00605865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00605865
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Use Investigation of Jzoloft.
- NCT number
- NCT00605865
- Status
- Completed
- Enrollment
- 2,272 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Panic Disorder, Depression
- Interventions
- Sertraline hydrochloride
- First posted
- 2008-01-31
- Last updated
- 2021-01-28
- Results first posted
- 2012-10-01
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants of Treatment Related Adverse Events (TRAEs) | Baseline up to 16 weeks | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. |
| Primary | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Baseline up to 16 weeks | |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.) |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.) |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor |
| Secondary | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not | Baseline up to 16 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor |
| Secondary | Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity | Baseline up to 16 weeks | Number of participants with responders of Sertraline to determine whether target disease severity is significant factor |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants of Treatment Related Adverse Events (TRAEs) | Baseline up to 16 weeks | Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline. | participants | NUMBER |
| PRIMARY | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Baseline up to 16 weeks | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | events | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Baseline up to 16 weeks | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Baseline up to 16 weeks | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Baseline up to 16 weeks | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Baseline up to 16 weeks | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose | Baseline up to 16 weeks | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Baseline up to 16 weeks | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | participants | NUMBER |
| SECONDARY | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not | Baseline up to 16 weeks | The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed. | participants | NUMBER |
| SECONDARY | Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity | Baseline up to 16 weeks | The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately). | participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants of Treatment Related Adverse Events (TRAEs) | Sertraline | 263 | participants | ||
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Sertraline | Dyspnoea | 3 | events | |
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Sertraline | Gastritis | 3 | events | |
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Sertraline | Sedation | 2 | events | |
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Sertraline | Erectile dysfunction | 2 | events | |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | With Complications | 129 | participants | ||
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Without Complications | 134 | participants | ||
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | With Concomitant Drug | 238 | participants | ||
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Without Concomitant Drug | 25 | participants | ||
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | With Renal Dysfunction | 7 | participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sertraline | 2,272 | |
| Overall Study | COMPLETED | Sertraline | 2,157 | |
| Overall Study | NOT COMPLETED | Sertraline | 115 |
Source ClinicalTrials.gov
Adverse events85
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Sertraline | 87 | 2,157 | 87 |
| other | Diarrhoea | Gastrointestinal disorders | Sertraline | 27 | 2,157 | 27 |
| other | Somnolence | Nervous system disorders | Sertraline | 23 | 2,157 | 23 |
| other | Constipation | Gastrointestinal disorders | Sertraline | 21 | 2,157 | 21 |
| other | Decreased appetite | Metabolism and nutrition disorders | Sertraline | 11 | 2,157 | 11 |
| other | Mania | Psychiatric disorders | Sertraline | 10 | 2,157 | 10 |
| other | Malaise | General disorders | Sertraline | 9 | 2,157 | 9 |
| other | Headache | Nervous system disorders | Sertraline | 8 | 2,157 | 8 |
| other | Dizziness | Nervous system disorders | Sertraline | 8 | 2,157 | 8 |
| other | Irritability | General disorders | Sertraline | 8 | 2,157 | 8 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sertraline | ||
| Total, other adverse events | Sertraline | 263 | 2,157 |
| Total, serious adverse events | Sertraline | 9 | 2,157 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| With Complications vs Without Complications: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications | Trial comparisons |
| With Concomitant Drug vs Without Concomitant Drug: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug | Trial comparisons |
With History of Treatment Prior to Sertraline vs Without History of Treatment Prior to Sertraline: Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride | Trial comparisons |
With Past Medical History of Other Illness vs Without Past Medical History of Other Illness: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Trial comparisons |
| Inpatient vs Outpatient: Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient | Trial comparisons |
| With Renal Dysfunction vs Without Renal Dysfunction: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Trial comparisons |
| 15 Years and Higher vs Under 15 Years: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not | Trial comparisons |
With Suicidal Ideation (Including Suicide Attempt) vs Without Suicidal Ideation (Including Suicide Attempt): Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt) | Trial comparisons |
With Complications vs Without Complications: Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments. | Trial comparisons |
| 15 Years and Higher vs Under 15 Years: Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00605865
GET https://conductscience.org/api/trials/v1/NCT00605865/results?page=2