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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

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, Psychotic Disorders, Psychoses

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

eyhchen@hku.hk

First Name & Middle Initial & Last Name or Official Title & Degree

Chung-Ming Leung, Bsc

Phone

852-64054460

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

bwschoi@hku.hk

12. IPD Sharing Statement

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Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia

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