Trial · NCT00605917

Special Investigation Of J Zoloft For Panic Disorder Patients

NCT00605917, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2012-09-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Special Investigation Of J Zoloft For Panic Disorder Patients. Trials, record NCT00605917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00605917

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Special Investigation Of J Zoloft For Panic Disorder Patients
NCT number: NCT00605917
Status: Completed
Enrollment: 997 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Panic Disorder
Interventions: Sertraline hydrochloride
First posted: 2008-01-31
Last updated: 2021-01-28
Results first posted: 2012-09-21

Source ClinicalTrials.gov

Registered outcomes14

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 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.
Primary	Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert	Baseline up to 52 weeks
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose	Baseline up to 52 weeks	Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether starting dose is significant risk factor
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug	Baseline up to 52 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: Family History of Psychiatric Disorder	Baseline up to 52 weeks	Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without family history of psychiatric disorder is significant risk factor
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status	Baseline up to 52 weeks	Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether smoking status 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 52 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: Non-Pharmaceutical Therapies	Baseline up to 52 weeks	Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without non-pharmaceutical therapies is significant risk factor
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline	Baseline up to 52 weeks	Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline is significant risk factor
Secondary	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose	Baseline up to 52 weeks	Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without average daily dose is significant risk factor

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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 52 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 52 weeks	The safety analysis population consists of the cases that satisfy the participants 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: Starting Dose	Baseline up to 52 weeks	The safety analysis population consists of the cases that satisfy the participants 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 52 weeks	The safety analysis population consists of the cases that satisfy the participants 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: Family History of Psychiatric Disorder	Baseline up to 52 weeks	The safety analysis population consists of the cases that satisfy the participants 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: Smoking Status	Baseline up to 52 weeks	The safety analysis population consists of the cases that satisfy the participants 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 52 weeks	The safety analysis population consists of the cases that satisfy the participants 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: Non-Pharmaceutical Therapies	Baseline up to 52 weeks	The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of was confirmed.	participants	NUMBER
SECONDARY	Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline	Baseline up to 52 weeks	The safety analysis population consists of the cases that satisfy the participants 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 52 weeks	The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.	participants	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group39

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants of Treatment Related Adverse Events (TRAEs)	Sertraline		110	participants
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert	Sertraline	Sedation	3	events
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert	Sertraline	Gastritis	2	events
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert	Sertraline	Hyperuricaemia	1	events
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert	Sertraline	Ventricular extrasystoles	1	events
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose	25mg		101	participants
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose	50mg		6	participants
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose	75mg		0	participants
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose	100mg		0	participants
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose	Other Than Those Above		3	participants

1 to 10 of 39Source ClinicalTrials.gov

See all 39 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sertraline	987
Overall Study	COMPLETED	Sertraline	908
Overall Study	NOT COMPLETED	Sertraline	79

Source ClinicalTrials.gov

Adverse events42

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	31	908	31
other	Somnolence	Nervous system disorders	Sertraline	17	908	17
other	Diarrhoea	Gastrointestinal disorders	Sertraline	13	908	13
other	Abdominal discomfort	Gastrointestinal disorders	Sertraline	9	908	9
other	Headache	Nervous system disorders	Sertraline	6	908	6
other	Malaise	General disorders	Sertraline	6	908	6
other	Dizziness	Nervous system disorders	Sertraline	5	908	5
other	Decreased appetite	Metabolism and nutrition disorders	Sertraline	3	908	3
other	Insomnia	Psychiatric disorders	Sertraline	3	908	3
other	Sedation	Nervous system disorders	Sertraline	3	908	3

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse 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	110	908
Total, serious adverse events	Sertraline	1	908

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 comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
With Non-pharmaceutical Therapies vs Without Non-pharmaceutical Therapies: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies	Trial comparisons
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 Concomitrant: Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug	Trial comparisons
With History of Treatment vs Without History of Treatment: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline	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
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 Complications vs Without Complications: Factors Considered to Affect the Efficacy of Sertraline: Complication	Trial comparisons
With Family History vs Without Family History: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder	Trial comparisons

Tests0

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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