Posttraumatic Stress Disorder
Conditions
Keywords
Retrospective, Sertraline, Posttraumatic stress disorder
Brief summary
This is a multicenter retrospective study to investigate the dosage regimens of sertraline in the treatment of Posttraumatic Stress Disorder (PTSD) under current medical practice and the efficacy and safety of this drug in patients with PTSD. Data will be collected from the medical records of patients with PTSD.
Detailed description
Patients with PTSD who have been dosed with sertraline from July 2006 (i.e., the start of marketing of this drug in Japan) or later to before contracting with each investigational site.
Interventions
Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with PTSD who have been dosed with sertraline since July 2006 or later. * Patients must be Japanese. * Patients should be started before the conclusion of a contract with each investigational site.
Exclusion criteria
* Not applicable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation | Up to 6 years | Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse. |
| Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation | Start of administration | Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. |
| Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation | Up to 6 years | Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. |
Countries
Japan
Participant flow
Recruitment details
Data were collected from the medical records of participants with post-traumatic stress disorder (PTSD) who have been dosed with sertraline since July 2006 (i.e., the start of marketing of this drug in Japan) or later. Treatment with sertraline had to be initiated before the conclusion of the contract with investigational sites.
Pre-assignment details
In this retrospective investigation, 123 patients were enrolled, but it was found during the data screening that one patient was not actually diagnosed with PTSD, and this patient was excluded from the investigation. Thus, 122 patients became subject to the investigation.
Participants by arm
| Arm | Count |
|---|---|
| SERTRALINE Participants with PTSD who were treated with sertraline as instructed by physicians. | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 15 |
| Overall Study | Continuation | 33 |
| Overall Study | Lack of Efficacy | 16 |
| Overall Study | Lost to Follow-up | 25 |
| Overall Study | Other | 4 |
Baseline characteristics
| Characteristic | SERTRALINE |
|---|---|
| Age, Continuous | 35.6 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male FEMALE | 119 Participants |
| Sex: Female, Male MALE | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 71 / 122 |
| serious Total, serious adverse events | 7 / 122 |
Outcome results
Primary
Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation
Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse.
Time frame: Up to 6 years
Population: Full analysis set (FAS) was defined as those who had a record of either CGI-I or Clinical Global Impression of Severity (CGI-S).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sertraline (Zoloft) | Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation | Very much improved | 23 Participants |
| Sertraline (Zoloft) | Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation | Much improved | 38 Participants |
| Sertraline (Zoloft) | Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation | Minimally improved | 25 Participants |
| Sertraline (Zoloft) | Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation | No change | 32 Participants |
| Sertraline (Zoloft) | Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation | Minimally worse | 4 Participants |
| Sertraline (Zoloft) | Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation | Much worse | 0 Participants |
| Sertraline (Zoloft) | Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation | Very much worse | 0 Participants |
Primary
Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation
Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
Time frame: Up to 6 years
Population: FAS was defined as those who had a record of either CGI-I or CGI-S.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation | Normal at end | 13 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation | Borderline at end | 19 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation | Mild at end | 40 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation | Moderate at end | 40 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation | Marked at end | 4 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation | Severe at end | 5 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation | The most severe at end | 1 Participants |
Primary
Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation
Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
Time frame: Start of administration
Population: FAS was defined as those who had a record of either CGI-I or CGI-S.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation | Normal at start | 0 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation | Borderline at start | 0 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation | Mild at start | 16 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation | Moderate at start | 68 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation | Marked at start | 17 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation | Severe at start | 20 Participants |
| Sertraline (Zoloft) | Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation | The most severe at start | 1 Participants |