UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020565 |
|---|---|
| Receipt number | R000023744 |
| Scientific Title | The effects of antipsychotics on sexual function and menstruation in female patients with mental disorders |
| Date of disclosure of the study information | 2016/01/14 |
| Last modified on | 2019/06/19 21:03:32 |
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Basic information
Public title
The effects of antipsychotics on sexual function and menstruation in female patients with mental disorders
Acronym
The effects of antipsychotics on sexual function and menstruation in women's mental illness
Scientific Title
The effects of antipsychotics on sexual function and menstruation in female patients with mental disorders
Scientific Title:Acronym
The effects of antipsychotics on sexual function and menstruation in women's mental illness
Region
| Japan |
Condition
Condition
female patients with mental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our purpose is to clarify the effects of antipsychotics on sexual function and menstruation in female patients with mental disorders
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
serum prolactin level, Visual analogue scale (VAS) assessment at the 2 months after the start of antipsychotics
Key secondary outcomes
weight change assessment at the 2 months after the start of antipsychotics
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with female mental disorders based on DSM-4-TR criteria:
continuous administration of antipsychitics
normal menstrual cycle before administration of antipsychotics
Key exclusion criteria
Patients who are pregnant or may become pregnant
Patients with sever hepatic disorder
Patients with sever kidney disorder
Patients with hypothyroidism
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakao Iwata |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL
0562-93-9259
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Matsuda |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL
0562-93-9259
Homepage URL
myuki@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
藤田保健衛生大学病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 14 | 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
| 2016 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Intended for female patients with mental disorders being treated with antipsychotics of 2 months same single agent, is compared with previous antipsychotics taking, after the antipsychotiscs taking, how much sexual function and menstruation was changed.
Management information
Registered date
| 2016 | Year | 01 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023744
