Depression, Panic Disorder
Conditions
Brief summary
Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this Special investigation is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug regarding long time use.
Detailed description
All the patients for whom an investigator prescribes the first sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Interventions
J ZOLOFT® Tablets 25 mg and J ZOLOFT® Tablets 50 mg. J ZOLOFT is Brand name in Japan. Dosage, Frequency: According to Japanese LPD, The usual initial dose of J ZOLOFT in adults is 25 mg daily as sertraline and then gradually increased up to 100 mg, which should be given orally once daily. The dose may be adjusted within the range not exceeding 100mg according to the patient's age and symptoms. Duration: According to the protocol of A0501091, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 52 weeks after the first administration.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).
Exclusion criteria
Patients not taking sertraline hydrochloride.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Baseline up to 52 weeks | — |
| Number of Participants of Treatment Related Adverse Events (TRAEs) | Baseline up to 52 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor |
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | Baseline up to 52 weeks | Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor |
| Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies | Baseline up to 52 weeks | Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor |
| Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt) | Baseline up to 52 weeks | Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sertraline Participants taking Sertraline according to Japanese Package Insert | 517 |
| Total | 517 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 25 |
Baseline characteristics
| Characteristic | Sertraline |
|---|---|
| Age, Customized <65 years | 447 participants |
| Age, Customized >=65 years | 70 participants |
| Complications Absent | 319 participants |
| Complications Present | 198 participants |
| Concomitant Drug Absent | 47 participants |
| Concomitant Drug Present | 470 participants |
| Sex: Female, Male Female | 311 Participants |
| Sex: Female, Male Male | 206 Participants |
| Starting Dose 100 mg | 6 participants |
| Starting Dose 25 mg | 348 participants |
| Starting Dose 50 mg | 144 participants |
| Starting Dose 75 mg | 10 participants |
| Starting Dose Other than those Above | 9 participants |
| Target Disease Depression/Depressed State | 426 participants |
| Target Disease Depression/Depressed State and Panic Disorder | 21 participants |
| Target Disease Other than those Above | 26 participants |
| Target Disease Panic Disorder | 44 participants |
| Target Disease Severity Mild | 111 participants |
| Target Disease Severity Moderate | 362 participants |
| Target Disease Severity Severe | 44 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 44 / 517 |
| serious Total, serious adverse events | 2 / 517 |
Outcome results
Primary
Number of Participants of Treatment Related Adverse Events (TRAEs)
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.
Time frame: Baseline up to 52 weeks
Population: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Sertraline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline Hydrochloride | Number of Participants of Treatment Related Adverse Events (TRAEs) | 44 events |
Primary
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sertraline Hydrochloride | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Erectile dysfunction | 2 events |
| Sertraline Hydrochloride | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Dissociative disorder | 1 events |
| Sertraline Hydrochloride | Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert | Completed suicide | 1 events |
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies
Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor
Time frame: Baseline up to 52 weeks
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline Hydrochloride | Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies | 141 participants |
| With Renal Dysfunction | Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies | 255 participants |
Comparison: The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with or without non-pharmaceutical therapies in the participants of responders.p-value: 0.04Chi-squared
Secondary
Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)
Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor
Time frame: Baseline up to 52 weeks
Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline Hydrochloride | Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt) | 29 participants |
| With Renal Dysfunction | Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt) | 63 participants |
Comparison: The risk factor tested was present or past history of intentional suicidal ideation. The null hypothesis is there is no difference between present or past history of intentional suicidal ideation (including suicide attempt) in the participants of responders.p-value: 0.004Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline Hydrochloride | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | 28 participants |
| With Renal Dysfunction | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness | 16 participants |
Comparison: The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders.p-value: <0.001Chi-squared
Secondary
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor
Time frame: Baseline up to 52 weeks
Population: The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sertraline Hydrochloride | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | 42 participants |
| With Renal Dysfunction | Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction | 2 participants |
Comparison: The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders.p-value: 0.003Chi-squared