UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028117 |
|---|---|
| Receipt number | R000032187 |
| Scientific Title | Drug Naive Females Affected With Mild to Moderate Depressive Disorder Are At Higher Risk Of Having Sexual Dysfunction Than Those Treated With Escitalopram: A Comparative Prospective Study |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2020/02/29 22:42:49 |
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Basic information
Public title
Drug Naive Females Affected With Mild to Moderate Depressive Disorder Are At Higher Risk Of Having Sexual Dysfunction Than Those Treated With Escitalopram: A Comparative Prospective Study
Acronym
Major depressive disroder and escitalopram
Scientific Title
Drug Naive Females Affected With Mild to Moderate Depressive Disorder Are At Higher Risk Of Having Sexual Dysfunction Than Those Treated With Escitalopram: A Comparative Prospective Study
Scientific Title:Acronym
Major depressive disroder and escitalopram
Region
| Africa |
Condition
Condition
urology
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
sexual functions in females with major depressive disorder receiving escitalopram
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the Arabic validated version of the female sexual function index (ArFSFI), the Arabic version of the center for epidemiological studies-depression CES-D score as well as the Arabic version of perceived stress situation (PSS) score, and the Arabic version of the patient health questionnaire (PHQ-9) score. The husbands of the female participants were evaluated separately by the validated Arabic version of the international index of erectile function
Key secondary outcomes
sexual functions in females with major depressive disorder receiving escitalopram
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group (A1) were receiving escitalopram 10-20 mg during the past 6 weeks before joining the study
Interventions/Control_2
Group (A 2) were drug naive females with mild to moderate depressive disorder for at least 6 months before joining this study
Interventions/Control_3
Group B served as controls included 60 healthy age and educational level matched volunteers who expressed interest to participate
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
The patients aged 18-40 years married and sexually active during the past 6 months. The Patients diagnosed with major depressive disorder according to the diagnostic and statistical manual of mental disorders, 4th edition and the patient health questionnaire-9
Key exclusion criteria
Any patient with severe depression indicated by a PHQ-9 score <10 was excluded
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | sameh |
| Middle name | |
| Last name | gamalel din |
Organization
Cairo University
Division name
Andrology & STDs
Zip code
202
Address
Alsaray street Elmanial
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | sameh |
| Middle name | |
| Last name | gamalel din |
Organization
Cairo University
Division name
Andrology department
Zip code
202
Address
Al-Saray Street, El Manial Cairo-11956-Egypt
TEL
01227109309
Homepage URL
samehfayek@kasralainy.edu.cu.eg
Sponsor or person
Institute
cairo university
Institute
Department
Personal name
Funding Source
Organization
cairo university
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
Beni-Suef University, Faculty of medicine
Address
Kasr Al-Ainy street behind the American embassy, Cairo-11956-Egypt
Tel
+20 2 904 051
ragabahmed63@yahoo.com
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
| 2017 | Year | 07 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 08 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 08 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 08 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032187
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