Trial Outcomes & Findings for Special Investigation Of Long Term Use Of Sertraline. (NCT NCT00605813)

NCT ID: NCT00605813

Last Updated: 2021-01-28

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 542 participants
• Primary outcome timeframe: Baseline up to 52 weeks
• Results posted on: 2021-01-28

Participant Flow

Participant milestones

Measure	Sertraline Participants taking Sertraline according to Japanese Package Insert
Overall Study STARTED	542
Overall Study COMPLETED	517
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	Sertraline Participants taking Sertraline according to Japanese Package Insert
Overall Study Protocol Violation	25

Baseline Characteristics

Special Investigation Of Long Term Use Of Sertraline.

Baseline characteristics by cohort

Measure	Sertraline n=517 Participants Participants taking Sertraline according to Japanese Package Insert
Age, Customized <65 years	447 participants n=5 Participants
Age, Customized >=65 years	70 participants n=5 Participants
Sex: Female, Male Female	311 Participants n=5 Participants
Sex: Female, Male Male	206 Participants n=5 Participants
Target Disease Depression/Depressed State	426 participants n=5 Participants
Target Disease Panic Disorder	44 participants n=5 Participants
Target Disease Depression/Depressed State and Panic Disorder	21 participants n=5 Participants
Target Disease Other than those Above	26 participants n=5 Participants
Target Disease Severity Mild	111 participants n=5 Participants
Target Disease Severity Moderate	362 participants n=5 Participants
Target Disease Severity Severe	44 participants n=5 Participants
Complications Present	198 participants n=5 Participants
Complications Absent	319 participants n=5 Participants
Concomitant Drug Present	470 participants n=5 Participants
Concomitant Drug Absent	47 participants n=5 Participants
Starting Dose 25 mg	348 participants n=5 Participants
Starting Dose 50 mg	144 participants n=5 Participants
Starting Dose 75 mg	10 participants n=5 Participants
Starting Dose 100 mg	6 participants n=5 Participants
Starting Dose Other than those Above	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 52 weeks

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

Outcome measures

Measure	Sertraline Hydrochloride n=517 Participants Participants who took Sertraline according to Japanese Package Insert	With Renal Dysfunction Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Erectile dysfunction	2 events	—
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Dissociative disorder	1 events	—
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert Completed suicide	1 events	—

PRIMARY outcome

Timeframe: Baseline up to 52 weeks

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

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.

Outcome measures

Measure	Sertraline Hydrochloride n=517 Participants Participants who took Sertraline according to Japanese Package Insert	With Renal Dysfunction Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
Number of Participants of Treatment Related Adverse Events (TRAEs)	44 events	—

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

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

Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor

Outcome measures

Measure	Sertraline Hydrochloride n=513 Participants Participants who took Sertraline according to Japanese Package Insert	With Renal Dysfunction n=4 Participants Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction	42 participants	2 participants

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

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

Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without past medical history of other illness is significant risk factor

Outcome measures

Measure	Sertraline Hydrochloride n=436 Participants Participants who took Sertraline according to Japanese Package Insert	With Renal Dysfunction n=81 Participants Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness	28 participants	16 participants

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor

Outcome measures

Measure	Sertraline Hydrochloride n=155 Participants Participants who took Sertraline according to Japanese Package Insert	With Renal Dysfunction n=266 Participants Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies	141 participants	255 participants

SECONDARY outcome

Timeframe: Baseline up to 52 weeks

Population: The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).

Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor

Outcome measures

Measure	Sertraline Hydrochloride n=35 Participants Participants who took Sertraline according to Japanese Package Insert	With Renal Dysfunction n=64 Participants Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)	29 participants	63 participants

Adverse Events

Sertraline

Serious events: 2 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sertraline n=517 participants at risk Participants taking Sertraline according to Japanese Package Insert
Psychiatric disorders Dissociative disorder	0.19% 1/517 • Number of events 1 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.
Psychiatric disorders Completed suicide	0.19% 1/517 • Number of events 1 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.

Other adverse events

Measure	Sertraline n=517 participants at risk Participants taking Sertraline according to Japanese Package Insert
Nervous system disorders Somnolence	1.7% 9/517 • Number of events 9 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.
Gastrointestinal disorders Nausea	1.4% 7/517 • Number of events 7 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.
Gastrointestinal disorders Diarrhoea	1.4% 7/517 • Number of events 7 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.
Gastrointestinal disorders Constipation	1.4% 7/517 • Number of events 7 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.
Psychiatric disorders Mania	0.77% 4/517 • Number of events 4 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.
Metabolism and nutrition disorders Decreased appetite	0.58% 3/517 • Number of events 3 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.
Reproductive system and breast disorders Ejaculation delayed	0.39% 2/517 • Number of events 2 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.
Reproductive system and breast disorders Erectile dysfunction	0.39% 2/517 • Number of events 2 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.
General disorders Malaise	0.39% 2/517 • Number of events 2 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.
Metabolism and nutrition disorders Increased appetite	0.19% 1/517 • Number of events 1 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.
Psychiatric disorders Dissociative disorder	0.19% 1/517 • Number of events 1 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.
Psychiatric disorders Completed suicide	0.19% 1/517 • Number of events 1 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.
Nervous system disorders Tremor	0.19% 1/517 • Number of events 1 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.
Nervous system disorders Headache	0.19% 1/517 • Number of events 1 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.
Eye disorders Visual impairment	0.19% 1/517 • Number of events 1 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.
Gastrointestinal disorders Abdominal discomfort	0.19% 1/517 • Number of events 1 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.
Skin and subcutaneous tissue disorders Alopecia	0.19% 1/517 • Number of events 1 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.
Investigations Weight increased	0.19% 1/517 • Number of events 1 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER