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Trial record 90 of 181 for:    "Panic Disorder"

Special Investigation Of Long Term Use Of Sertraline.

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ClinicalTrials.gov Identifier: NCT00605813
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : September 10, 2012
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Depression
Panic Disorder
Intervention Drug: Sertraline hydrochloride
Enrollment 542
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sertraline
Hide Arm/Group Description Participants taking Sertraline according to Japanese Package Insert
Period Title: Overall Study
Started 542
Completed 517
Not Completed 25
Reason Not Completed
Protocol Violation             25
Arm/Group Title Sertraline
Hide Arm/Group Description Participants taking Sertraline according to Japanese Package Insert
Overall Number of Baseline Participants 517
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 517 participants
<65 years 447
>=65 years 70
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 517 participants
Female
311
  60.2%
Male
206
  39.8%
Target Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 517 participants
Depression/Depressed State 426
Panic Disorder 44
Depression/Depressed State and Panic Disorder 21
Other than those Above 26
[1]
Measure Description: The target disease which was diagnosed by investigator
Target Disease Severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 517 participants
Mild 111
Moderate 362
Severe 44
[1]
Measure Description: The severity of target disease which was diagnosed by investigator
Complications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 517 participants
Present 198
Absent 319
[1]
Measure Description: 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.)
Concomitant Drug   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 517 participants
Present 470
Absent 47
[1]
Measure Description: 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.)
Starting Dose   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 517 participants
25 mg 348
50 mg 144
75 mg 10
100 mg 6
Other than those Above 9
[1]
Measure Description: Starting dose of each participant enrolled in this study
1.Primary Outcome
Title Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
Hide Description [Not Specified]
Time Frame Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
Arm/Group Title Sertraline Hydrochloride
Hide Arm/Group Description:
Participants who took Sertraline according to Japanese Package Insert
Overall Number of Participants Analyzed 517
Measure Type: Number
Unit of Measure: events
Erectile dysfunction 2
Dissociative disorder 1
Completed suicide 1
2.Primary Outcome
Title Number of Participants of Treatment Related Adverse Events (TRAEs)
Hide Description 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.
Time Frame Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Sertraline.
Arm/Group Title Sertraline
Hide Arm/Group Description:
Participants who took Sertraline according to Japanese Package Insert
Overall Number of Participants Analyzed 517
Measure Type: Number
Unit of Measure: events
44
3.Secondary Outcome
Title Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
Hide Description Number of participants with Treatment Related Adverse Events (TRAEs) of Sertralinedine to determine whether with or without renal dysfunction is significant risk factor
Time Frame Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
Arm/Group Title Without Renal Dysfunction With Renal Dysfunction
Hide Arm/Group Description:
Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
Overall Number of Participants Analyzed 513 4
Measure Type: Number
Unit of Measure: participants
42 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Without Renal Dysfunction, With Renal Dysfunction
Comments The risk factor tested was "renal dysfunction". The null hypothesis is there is no difference between "with and without renal dysfunction" in the participants of responders.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments not adjusted, p=0.050
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness
Hide Description 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
Time Frame Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of Sertraline was confirmed.
Arm/Group Title Without Past Medical History of Other Illness With Past Medical History of Other Illness
Hide Arm/Group Description:
Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
Overall Number of Participants Analyzed 436 81
Measure Type: Number
Unit of Measure: participants
28 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Without Past Medical History of Other Illness, With Past Medical History of Other Illness
Comments The risk factor tested was "past medical history of other illness". The null hypothesis is there is no difference between "with and without past medical history of other illness" in the participants of responders.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments not adjusted, p=0.050
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies
Hide Description Number of participants with responders of Sertraline to determine whether with or without non-pharmaceutical therapies is significant factor
Time Frame Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Arm/Group Title With Non-pharmaceutical Therapies Without Non-pharmaceutical Therapies
Hide Arm/Group Description:
Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
Overall Number of Participants Analyzed 155 266
Measure Type: Number
Unit of Measure: participants
141 255
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection With Non-pharmaceutical Therapies, Without Non-pharmaceutical Therapies
Comments The risk factor tested was "non-pharmaceutical therapies". The null hypothesis is there is no difference between "with or without non-pharmaceutical therapies" in the participants of responders.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments not adjusted, p=0.050
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)
Hide Description Number of participants with responders of Sertraline to determine whether present or past history of intentional suicidal ideation (including suicide attempt) is significant factor
Time Frame Baseline up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).
Arm/Group Title Past History of Intentional Suicidal Ideation Present History of Intentional Suicidal Ideation
Hide Arm/Group Description:
Participants with past history of intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
Participants with present intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
Overall Number of Participants Analyzed 35 64
Measure Type: Number
Unit of Measure: participants
29 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Past History of Intentional Suicidal Ideation, Present History of Intentional Suicidal Ideation
Comments The risk factor tested was "present or past history of intentional suicidal ideation". The null hypothesis is there is no difference between "present or past history of intentional suicidal ideation (including suicide attempt)" in the participants of responders.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments not adjusted, p=0.050
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
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
Hide Arm/Group Description Participants taking Sertraline according to Japanese Package Insert
All-Cause Mortality
Sertraline
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sertraline
Affected / at Risk (%) # Events
Total   2/517 (0.39%)    
Psychiatric disorders   
Dissociative disorder  1  1/517 (0.19%)  1
Completed suicide  1  1/517 (0.19%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA/14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sertraline
Affected / at Risk (%) # Events
Total   44/517 (8.51%)    
Eye disorders   
Visual impairment  1  1/517 (0.19%)  1
Gastrointestinal disorders   
Nausea  1  7/517 (1.35%)  7
Diarrhoea  1  7/517 (1.35%)  7
Constipation  1  7/517 (1.35%)  7
Abdominal discomfort  1  1/517 (0.19%)  1
General disorders   
Malaise  1  2/517 (0.39%)  2
Investigations   
Weight increased  1  1/517 (0.19%)  1
Metabolism and nutrition disorders   
Decreased appetite  1  3/517 (0.58%)  3
Increased appetite  1  1/517 (0.19%)  1
Nervous system disorders   
Somnolence  1  9/517 (1.74%)  9
Tremor  1  1/517 (0.19%)  1
Headache  1  1/517 (0.19%)  1
Psychiatric disorders   
Mania  1  4/517 (0.77%)  4
Dissociative disorder  1  1/517 (0.19%)  1
Completed suicide  1  1/517 (0.19%)  1
Reproductive system and breast disorders   
Ejaculation delayed  1  2/517 (0.39%)  2
Erectile dysfunction  1  2/517 (0.39%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  1/517 (0.19%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA/14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00605813     History of Changes
Other Study ID Numbers: A0501091
First Submitted: January 18, 2008
First Posted: January 31, 2008
Results First Submitted: August 9, 2012
Results First Posted: September 10, 2012
Last Update Posted: September 10, 2012