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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sertraline (Zoloft) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline (Zoloft) | Drug | Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 years |
| 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. | Start of administration |
| 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. | Up to 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with PTSD
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KURUME University School of Medicine | Kurume | Fukuoka | Japan | |||
| Hyogo Institute for Traumatic Stress |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27923359 | Derived | Kamo T, Maeda M, Oe M, Kato H, Shigemura J, Kuribayashi K, Hoshino Y. Dosage, effectiveness, and safety of sertraline treatment for posttraumatic stress disorder in a Japanese clinical setting: a retrospective study. BMC Psychiatry. 2016 Dec 7;16(1):434. doi: 10.1186/s12888-016-1138-5. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | SERTRALINE | Participants with post-traumatic stress disorder (PTSD) who were treated with sertraline as instructed by physicians |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Chuo-ku,Kobe-city |
| Hyōgo |
| Japan |
| National Defense Medical College/Department of Psychiatry | Tokorozawa | Saitama | Japan |
| Institute of Women?s Health Tokyo Women?s Medical University | Shinjyuku-ku | Tokyo | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SERTRALINE | Participants with PTSD who were treated with sertraline as instructed by physicians. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full analysis set (FAS) was defined as those who had a record of either CGI-I or Clinical Global Impression of Severity (CGI-S). | Posted | Number | Participants | Up to 6 years |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | FAS was defined as those who had a record of either CGI-I or CGI-S. | Posted | Number | Participants | Start of administration |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | FAS was defined as those who had a record of either CGI-I or CGI-S. | Posted | Number | Participants | Up to 6 years |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SERTRALINE | Participants with PTSD who were treated with sertraline as instructed by physicians | 7 | 122 | 71 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Thinking abnormal | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Defaecation urgency | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Heat illness | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood prolactin increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperphagia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sleep paralysis | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Activation syndrome | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Withdrawal syndrome | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
|
|