Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
glucose drink
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, Psychotic Disorders, Psychoses
Eligibility Criteria
Inclusion Criteria:
- Aged 15 or above
- DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis NOS or delusional disorder
- Cantonese-speaking Chinese
- Ability to understand the nature of the study and sign informed consent
Exclusion Criteria:
- Organic Brain disorder
- Known history of intellectual disability
- Priority Follow Up (Subtarget or Target)
- All allergic to any sugar or artificial sweeteners
- Diabetics
- Physical Disability
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
No Intervention
No Intervention
Arm Label
Glucose & Depleting
Glucose & non-depleting
Placebo & depleting
Placebo & non depleting
Arm Description
participants will perform in a depleting task and receive a glucose drink
participants will perform in a non-depleting task and receive a glucose drink
participants will perform in a depleting task and receive a placebo drink
participants will perform in a non depleting task and receive a placebo drink
Outcomes
Primary Outcome Measures
Blood Glucose Level
self control tasks (handgrip, stroop, figure tracing task)
Secondary Outcome Measures
Full Information
NCT ID
NCT01563016
First Posted
March 22, 2012
Last Updated
March 23, 2012
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01563016
Brief Title
Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia
Official Title
Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The research aims to investigate the relationship between self-control ability and blood glucose level in schizophrenic patients. The main purpose of the present study is to explore whether the close relationship of blood glucose and self-regulatory strength observed in healthy individuals, is applicable to schizophrenic patients. More specifically, the current study aims
to investigate whether the exertion of self-control reduces blood glucose,
to examine whether low level of blood glucose deteriorates subsequent self-control performances
to examine whether restoring the glucose level eliminates these impairments, in schizophrenic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, Psychotic Disorders, Psychoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glucose & Depleting
Arm Type
Experimental
Arm Description
participants will perform in a depleting task and receive a glucose drink
Arm Title
Glucose & non-depleting
Arm Type
Placebo Comparator
Arm Description
participants will perform in a non-depleting task and receive a glucose drink
Arm Title
Placebo & depleting
Arm Type
No Intervention
Arm Description
participants will perform in a depleting task and receive a placebo drink
Arm Title
Placebo & non depleting
Arm Type
No Intervention
Arm Description
participants will perform in a non depleting task and receive a placebo drink
Intervention Type
Dietary Supplement
Intervention Name(s)
glucose drink
Intervention Description
participants will receive a drink rich in glucose
Primary Outcome Measure Information:
Title
Blood Glucose Level
Time Frame
baseline, after depleting task
Title
self control tasks (handgrip, stroop, figure tracing task)
Time Frame
after 12-minutes metabolizing phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 15 or above
DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis NOS or delusional disorder
Cantonese-speaking Chinese
Ability to understand the nature of the study and sign informed consent
Exclusion Criteria:
Organic Brain disorder
Known history of intellectual disability
Priority Follow Up (Subtarget or Target)
All allergic to any sugar or artificial sweeteners
Diabetics
Physical Disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric YH Chen, MD
Phone
852-22553063
Email
eyhchen@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Chung-Ming Leung, Bsc
Phone
852-64054460
Email
mingming4f29@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric YH Chen, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonnie Choi
Email
bwschoi@hku.hk
12. IPD Sharing Statement
Learn more about this trial
Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia
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