UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Action investigation of carnitine in patients with anorexia nervosa
Title of the study (Brief title)	CAN
Region	Japan

Condition
Condition	Anorexia Nervosa
Classification by specialty	Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	*To test blood carnitine levels in patients with anorexia nervosa *To assess the correlation of carnitine and the psychiatric manifestation in patients with anorexia nervosa
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	The body weight, blood carnitine levels, Symptom Rating Scale for Eating Disorders, General Health Questionnaire, Beck`s Depression Inventory-Second Ed, State-Trait Anxiety Inventory, Child Behavior Checklist, Global Assessment of Functioning, NIMH Global Obsessive-Compulsive Scale at start of therapy and finish of therapy, BMI exceeds 16.
Key secondary outcomes	Nutritional Status; ALB, Pre ALB, RBP Liver Function; AST, ALT, gamma GTP Renal Funciton; Creatinine, BUN

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	13 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients with anorexia nervosa admitted to the department of psychiatry of Shiga University of Medical Science Hospital
Key exclusion criteria	*Arbitrary Hospitalization When the patient or the protector does not agree to study *Involuntary Hospitalization When the protector does not agree to study
Target sample size	30

Research contact person
Name of lead principal investigator	Takahiko Inagaki
Organization	Shiga University of Medical Science
Division name	Department of Community Psychiatric Medicine
Address	Seta Tsukinowa-cho, Otsu City, Shiga, JAPNA
TEL	077-548-2291
Email	kerosuke@belle.shiga-med.ac.jp

Public contact
Name of contact person	Takahiko Inagaki
Organization	Shiga University of Medical Science
Division name	Department of Community Psychiatric Medicine
Address	Seta Tsukinowa-cho, Otsu City, Shiga, JAPNA
TEL	077-548-2291
Homepage URL
Email	kerosuke@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Community Psychiatric Medicine of Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	滋賀医科大学医学部附属病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 01 Month 17 Day
Anticipated trial start date	2014 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We assess the weight, blood carnitine levels, nutritional status, liver function, renal function, psychiatric manifestation at start of treatment and finish of treatment,BMI >= 16.

Management information
Registered date	2014 Year 01 Month 17 Day
Last modified on	2018 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015063