Special Investigation Of Long Term Use Of Sertraline.

NCT00605813 | Completed Results

• 1 other identifier: A0501091
• Study Type: observational
• Target: 542
• Locations: 0 countries
• Sites: N/A

Brief Summary

Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" 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 regarding long time use.

Conditions

Depression; Panic Disorder

Outcome Measures

Primary Outcomes (2)

• Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert

  Baseline up to 52 weeks

• 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.

  Baseline up to 52 weeks

Secondary Outcomes (4)

• Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction

  Baseline up to 52 weeks

• Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness

  Baseline up to 52 weeks

• Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies

  Baseline up to 52 weeks

• Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)

  Baseline up to 52 weeks

Study Arms (1)

Sertraline hydrochloride.

Patients taking Sertraline hydrochloride.

Drug: Sertraline hydrochloride

Interventions

Sertraline hydrochloride DRUG

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 A0501091, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 52 weeks after the first administration.

Also known as: J Zoloft, Zoloft

Sertraline hydrochloride.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients to whom an investigator involved in A0501091 prescribes sertraline hydrochloride.

You may qualify if:

• The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).

You may not qualify if:

• Patients not taking sertraline hydrochloride.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Depression; Panic Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 28, 2021
• Results First Posted: September 10, 2012

Record last verified: 2021-01