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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name