A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01607593
• Collaborator: (none)
• Enrollment: 123
• Locations: 4
• Duration (Months): 2
• Patients Per Site: 30.8
• Patients Per Site Per Month: 15.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Drug: sertraline (Zoloft)

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 123 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
sertraline (Zoloft)	Drug: sertraline (Zoloft); Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KURUME University School of Medicine	Kurume-city	Fukuoka	Japan
2	Hyogo Institute for Traumatic Stress	Chuo-ku,Kobe-city	Hyogo	Japan
3	National Defense Medical College/Department of Psychiatry	Tokorozawa-city	Saitama	Japan
4	Institute of Women?s Health Tokyo Women?s Medical University	Shinjyuku-ku	Tokyo	Japan

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01607593
• Other Study ID Numbers: A0501099
• First Posted: May 30, 2012
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Retrospective; Sertraline; Posttraumatic stress disorder
• Additional relevant MeSH terms: Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Sertraline

Study Results

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 Detail	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.

Arm/Group Title	SERTRALINE
Arm/Group Description	Participants with post-traumatic stress disorder (PTSD) who were treated with sertraline as instructed by physicians
Period Title: Overall Study
STARTED	122
COMPLETED	29
NOT COMPLETED	93

Baseline Characteristics

Arm/Group Title	SERTRALINE
Arm/Group Description	Participants with PTSD who were treated with sertraline as instructed by physicians.
Overall Participants	122
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.6 (10.4)
Sex: Female, Male (Count of Participants)
FEMALE	119 97.5%
MALE	3 2.5%

Outcome Measures

1. Primary Outcome

Title	Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sertraline (Zoloft)
Arm/Group Description	Participants with PTSD who were treated with sertraline as instructed by physicians
Measure Participants	122
Very much improved	23 18.9%
Much improved	38 31.1%
Minimally improved	25 20.5%
No change	32 26.2%
Minimally worse	4 3.3%
Much worse	0 0%
Very much worse	0 0%

2. Primary Outcome

Title	Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation
Description	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

Outcome Measure Data

Analysis Population Description

FAS was defined as those who had a record of either CGI-I or CGI-S.

Arm/Group Title	Sertraline (Zoloft)
Arm/Group Description	Participants with PTSD who were treated with sertraline as instructed by physicians
Measure Participants	122
Normal at start	0 0%
Borderline at start	0 0%
Mild at start	16 13.1%
Moderate at start	68 55.7%
Marked at start	17 13.9%
Severe at start	20 16.4%
The most severe at start	1 0.8%

3. Primary Outcome

Title	Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation
Description	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

Outcome Measure Data

Analysis Population Description

FAS was defined as those who had a record of either CGI-I or CGI-S.

Arm/Group Title	Sertraline (Zoloft)
Arm/Group Description	Participants with PTSD who were treated with sertraline as instructed by physicians
Measure Participants	122
Normal at end	13 10.7%
Borderline at end	19 15.6%
Mild at end	40 32.8%
Moderate at end	40 32.8%
Marked at end	4 3.3%
Severe at end	5 4.1%
The most severe at end	1 0.8%

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	SERTRALINE
Arm/Group Description	Participants with PTSD who were treated with sertraline as instructed by physicians
All Cause Mortality
	SERTRALINE
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SERTRALINE
	Affected / at Risk (%)	# Events
Total	7/122 (5.7%)
Injury, poisoning and procedural complications
Intentional overdose	1/122 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	1/122 (0.8%)
Ovarian neoplasm	1/122 (0.8%)
Pituitary tumour	1/122 (0.8%)
Psychiatric disorders
Hallucination	1/122 (0.8%)
Intentional self-injury	1/122 (0.8%)
Suicide attempt	1/122 (0.8%)
Thinking abnormal	1/122 (0.8%)
Other (Not Including Serious) Adverse Events
	SERTRALINE
	Affected / at Risk (%)	# Events
Total	71/122 (58.2%)
Cardiac disorders
Palpitations	3/122 (2.5%)
Ear and labyrinth disorders
Hypoacusis	1/122 (0.8%)
Meniere's disease	1/122 (0.8%)
Tinnitus	1/122 (0.8%)
Eye disorders
Eye pain	1/122 (0.8%)
Photopsia	1/122 (0.8%)
Visual acuity reduced	1/122 (0.8%)
Vitreous floaters	1/122 (0.8%)
Gastrointestinal disorders
Abdominal discomfort	5/122 (4.1%)
Abdominal pain	1/122 (0.8%)
Abdominal pain upper	5/122 (4.1%)
Constipation	2/122 (1.6%)
Defaecation urgency	1/122 (0.8%)
Diarrhoea	7/122 (5.7%)
Dry mouth	7/122 (5.7%)
Melaena	1/122 (0.8%)
Nausea	12/122 (9.8%)
Stomatitis	1/122 (0.8%)
General disorders
Asthenia	1/122 (0.8%)
Chest discomfort	1/122 (0.8%)
Feeling abnormal	2/122 (1.6%)
Inflammation	1/122 (0.8%)
Influenza like illness	1/122 (0.8%)
Malaise	1/122 (0.8%)
Pyrexia	4/122 (3.3%)
Hepatobiliary disorders
Drug-induced liver injury	1/122 (0.8%)
Hepatic function abnormal	2/122 (1.6%)
Immune system disorders
Seasonal allergy	1/122 (0.8%)
Infections and infestations
Cystitis	1/122 (0.8%)
Herpes virus infection	2/122 (1.6%)
Herpes zoster	1/122 (0.8%)
Nasopharyngitis	2/122 (1.6%)
Oral herpes	1/122 (0.8%)
Skin infection	1/122 (0.8%)
Upper respiratory tract infection	1/122 (0.8%)
Injury, poisoning and procedural complications
Heat illness	1/122 (0.8%)
Intentional overdose	4/122 (3.3%)
Road traffic accident	1/122 (0.8%)
Investigations
Blood cholesterol increased	1/122 (0.8%)
Blood pressure increased	1/122 (0.8%)
Blood prolactin increased	1/122 (0.8%)
Blood triglycerides increased	1/122 (0.8%)
Urine output decreased	1/122 (0.8%)
Weight increased	2/122 (1.6%)
White blood cell count increased	2/122 (1.6%)
Metabolism and nutrition disorders
Decreased appetite	2/122 (1.6%)
Hyperlipidaemia	1/122 (0.8%)
Hyperphagia	4/122 (3.3%)
Polydipsia	1/122 (0.8%)
Musculoskeletal and connective tissue disorders
Back pain	3/122 (2.5%)
Musculoskeletal chest pain	1/122 (0.8%)
Musculoskeletal stiffness	2/122 (1.6%)
Neck pain	1/122 (0.8%)
Nervous system disorders
Dizziness	4/122 (3.3%)
Dysarthria	1/122 (0.8%)
Headache	12/122 (9.8%)
Hypoaesthesia	3/122 (2.5%)
Sleep paralysis	1/122 (0.8%)
Somnolence	11/122 (9%)
Tremor	3/122 (2.5%)
Psychiatric disorders
Activation syndrome	1/122 (0.8%)
Alcoholism	1/122 (0.8%)
Disorientation	1/122 (0.8%)
Eating disorder	1/122 (0.8%)
Insomnia	2/122 (1.6%)
Intentional self-injury	2/122 (1.6%)
Mania	1/122 (0.8%)
Self injurious behaviour	2/122 (1.6%)
Sleep disorder	1/122 (0.8%)
Withdrawal syndrome	1/122 (0.8%)
Renal and urinary disorders
Dysuria	1/122 (0.8%)
Urinary retention	1/122 (0.8%)
Reproductive system and breast disorders
Menopausal symptoms	1/122 (0.8%)
Menorrhagia	1/122 (0.8%)
Metrorrhagia	1/122 (0.8%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	3/122 (2.5%)
Yawning	3/122 (2.5%)
Skin and subcutaneous tissue disorders
Alopecia	2/122 (1.6%)
Dry skin	2/122 (1.6%)
Eczema	3/122 (2.5%)
Night sweats	2/122 (1.6%)
Pruritus	2/122 (1.6%)
Rash	1/122 (0.8%)
Urticaria	1/122 (0.8%)
Vascular disorders
Hypotension	1/122 (0.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.