UMIN-CTR Clinical Trial

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

Major Depressive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Himorogi Psychiatric Institute

Institute

Department

Personal name

Organization

Himorogi Psychiatric Institute

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

06

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

06

Month

13

Day

Last modified on

2013

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012805