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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010950
Receipt No. R000012805
Scientific Title Patient Satisfaction after Switching to Paroxetine CR: A Follow-up Study Using HSDS/HSAS (Himorogi Self-rating Depression/Anxiety Scale)
Date of disclosure of the study information 2013/06/13
Last modified on 2013/06/14

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Basic information
Public title Patient Satisfaction after Switching to
Paroxetine CR: A Follow-up Study Using HSDS/HSAS (Himorogi Self-rating Depression/Anxiety Scale)
Acronym Patient Satisfaction after Switching to
Paroxetine CR
Scientific Title Patient Satisfaction after Switching to
Paroxetine CR: A Follow-up Study Using HSDS/HSAS (Himorogi Self-rating Depression/Anxiety Scale)
Scientific Title:Acronym Patient Satisfaction after Switching to
Paroxetine CR
Region
Japan

Condition
Condition Major Depressive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the difference between paroxetine IR and paroxetine CR in treatment efficacy, safety profile, and patient satisfaction by using each patient's self-rating on his/her own symptoms of depression and/or anxiety when paroxetine IR is switched to paroxetine CR in equivalent doses.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoints of efficacy are the frequencies of adverse drug reactions (ADRs) as well as the total scores of HSDS/HSAS (Himorogi Self-rating Depression/Anxiety Scale) evaluated at the time of medication change from paroxetine IR to paroxetine CR (0W), during the 4th week (4W), and during the 8th week (8W) of the trial.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A total of 256 patients were enrolled in the study: 205 patients who switched from paroxetine IR to paroxetine CR and 51 naive patients. Out of them, 139 switchover patients and 29 naive patients, who were the analyzed subjects for efficacy, conducted their self-assessments at the time of medication change or initiation of treatment (0W) as well as in the 4th week (4W) and in the 8th week (8W) after switching the medication. The trial was conducted from June 23, 2012 to October 31, 2012.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria were as follows:
1) Those aged 18 or over with MDD or anxiety disorder complication of MDD (by DSM-IV-TR).
2) Those treated with stable doses of paroxetine IR for at least 24 weeks presenting with stable symptoms, or those newly treated with paroxetine CR.
3) Gender and frequencies of past depression episodes do not matter.
Key exclusion criteria The exclusion criteria were as follows:
1) Those with convulsive disorders such as schizophrenia and epilepsia or their previous history.
2) Those with depression or depressive state caused by organic brain damages.
3) Those with severe disorders in liver, kidney, blood or circulation.
4) Those with malignancy or its previous history.
5) Those pregnant, nursing, or who may become pregnant.
6) Those with heavy suicidal tendency, previous history of suicidal ideation, or suicide attempt.
7) Those with personality
disorder, mental retardation or intractable depression at a physician's discretion.
8) Those with substance dependence or drug abuse (excluding disorders related to nicotine).
9) Those who have had modified doses of concomitant drugs (excluding paroxetine CR) during the last 8 weeks.

Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Watanabe
Organization Himorogi Psychiatric Institute
Division name Head Director
Zip code
Address Housei-Daiichi Bldg. 5F, 1-20-10 Sugamo, Toshima-ku, Tokyo 170-0002, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Watanabe
Organization Himorogi Psychiatric Institute
Division name Head Director
Zip code
Address Housei-Daiichi Bldg. 5F, 1-20-10 Sugamo, Toshima-ku, Tokyo 170-0002, Japan
TEL 03-5940-5547
Homepage URL
Email watanabe@himorogi.org

Sponsor
Institute Himorogi Psychiatric Institute
Institute
Department

Funding Source
Organization Himorogi Psychiatric Institute
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 13 Day
Last modified on
2013 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012805

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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