Panic DisorderNCT00605865

Drug Use Investigation of Jzoloft.

An observational study of Panic Disorder and Depression, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this surveillance 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Panic Disorder, Depression
What is being tested?: Sertraline hydrochloride
Type of treatment: Pill or oral medicine
How many people: 2,272 participants
Where: No sites listed yet
Study dates: Apr 2007to Sep 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The patients to whom an investigator involved in A0501090 prescribes sertraline hydrochloride.

Who may be able to join

Patients need to be taking Sertraline hydrochloride in order to be enrolled in the surveillance.

Who cannot join

Patients not taking Sertraline hydrochloride.

About this study

Read the detailed description

All the patients 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.

Conditions: Panic Disorder, Depression
Being tested: Sertraline hydrochloride
Medical subject headings: Panic Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sertraline hydrochlorideDrug
Also called J Zoloft, Zoloft
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 A0501090, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 16 weeks after the first administration.

Study groups in NCT00605865
Study group	Role	What they receive
Sertraline hydrochloride.		Patients taking Sertraline hydrochloride. Receives: Drug: Sertraline hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline up to 16 weeks
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Measured: Baseline up to 16 weeks

Secondary outcomes (14)

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without complications is significant risk factor, Complications is the patient's current experiences with illnesses, operations, injuries and treatments. The physician of this survey made the diagnosis. (e.g. hypertension, diabetes, etc.)
Measured: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
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.)
Measured: Baseline up to 16 weeks
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 Sertraline to determine whether with or without renal dysfunction is significant risk factor
Measured: Baseline up to 16 weeks
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 Sertraline to determine whether with or without Past Medical History of Other Illness is significant risk factor
Measured: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether average daily dose is significant risk factor
Measured: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant risk factor
Measured: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether 15 years and higher of age or not is significant risk factor
Measured: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity
Number of participants with responders of Sertraline to determine whether target disease severity is significant factor
Measured: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride
Number of participants with responders of Sertraline to determine whether with or without history of treatment prior to administration of Sertraline hydrochloride is significant factor
Measured: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient
Number of participants with responders of Sertraline to determine whether outpatient or inpatient is significant factor
Measured: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.
Number of participants with responders of Sertraline to determine whether with or without complication is significant factor
Measured: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not
Number of participants with responders of Sertraline to determine whether 15 years and higher of age or not is significant factor
Measured: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Age
Number of participants with responders of Sertraline to determine whether age is significant factor
Measured: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)
Number of participants with responders of Sertraline to determine whether with or without suicidal ideation (including suicide attempt) is significant factor
Measured: Baseline up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Sep 2011

First posted31 Jan 2008 (estimated)
Study startApr 2007
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Panic DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 2,272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00605865
Sponsor's protocol ID: A0501090
Status last verified: Jan 2021
First submitted: 18 Jan 2008
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Panic Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Use Investigation of Jzoloft.
ClinicalTrials.gov ID: NCT00605865
Acronym / sponsor ID: A0501090
Conditions: Panic Disorder, Depression
Study type: Observational
Recruitment status: Completed
Enrolment: 2,272 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 31 Jan 2008 (estimated)
Results: Posted 1 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Sertraline hydrochloride.	–	Drug: Sertraline hydrochloridePatients taking Sertraline hydrochloride.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The patients to whom an investigator involved in A0501090 prescribes sertraline hydrochloride.

Key inclusion criteria (1 listed)

Patients need to be taking Sertraline hydrochloride in order to be enrolled in the surveillance.

Key exclusion criteria (1 listed)

Patients not taking Sertraline hydrochloride.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sertraline hydrochlorideAlso: J Zoloft, ZoloftJ 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 A0501090, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 16 weeks after the first administration.	Drug	Sertraline hydrochloride.

Primary outcome

Number of Participants of Treatment Related Adverse Events (TRAEs)
Time frame: Baseline up to 16 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.
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Time frame: Baseline up to 16 weeks

14 secondary outcomes

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications
Time frame: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
Time frame: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
Time frame: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
Time frame: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose
Time frame: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Suicidal Ideation (Including Suicide Attempt)
Time frame: Baseline up to 16 weeks
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: 15 Years and Higher of Age or Not
Time frame: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Target Disease Severity
Time frame: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: History of Treatment Prior to Administration of Sertraline Hydrochloride
Time frame: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Outpatient/Inpatient
Time frame: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Complication ;Complications is the Patient's Current Experiences With Illnesses, Operations, Injuries and Treatments.
Time frame: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: 15 Years and Higher of Age or Not
Time frame: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Age
Time frame: Baseline up to 16 weeks
Factors Considered to Affect the Efficacy of Sertraline: Suicidal Ideation (Including Suicide Attempt)
Time frame: Baseline up to 16 weeks

Results and safety

Results posted to the registry on 1 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sertraline	2,272	2,157

Primary outcome: Number of Participants of Treatment Related Adverse Events (TRAEs)

Time frame: Baseline up to 16 weeks. Number. Unit: participants

Measure	Sertraline n = 2157
Value	263

Population analysed: Safety analysis population included all enrolled participants who had received at least 1 confirmed administration of Sertraline.

Primary outcome: Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert

Time frame: Baseline up to 16 weeks. Number. Unit: events

Measure	Sertraline n = 2157
Dyspnoea	3
Gastritis	3
Sedation	2
Erectile dysfunction	2

Population analysed: The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sertraline	9 of 2,157 (0.4%)	263 of 2,157 (12.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Not yet recruiting
A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder
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Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Panic Disorder and Depression, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants of Treatment Related Adverse Events (TRAEs) (time frame: Baseline up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00605865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.