NCT01563016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

March 22, 2012

Last Update Submit

March 23, 2012

Conditions

Keywords

schizophreniaPsychotic DisordersPsychoses

Outcome Measures

Primary Outcomes (2)

  • Blood Glucose Level

    baseline, after depleting task

  • self control tasks (handgrip, stroop, figure tracing task)

    after 12-minutes metabolizing phase

Study Arms (4)

Glucose & Depleting

EXPERIMENTAL

participants will perform in a depleting task and receive a glucose drink

Dietary Supplement: glucose drink

Glucose & non-depleting

PLACEBO COMPARATOR

participants will perform in a non-depleting task and receive a glucose drink

Dietary Supplement: glucose drink

Placebo & depleting

NO INTERVENTION

participants will perform in a depleting task and receive a placebo drink

Placebo & non depleting

NO INTERVENTION

participants will perform in a non depleting task and receive a placebo drink

Interventions

glucose drinkDIETARY_SUPPLEMENT

participants will receive a drink rich in glucose

Glucose & DepletingGlucose & non-depleting

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Eric YH Chen, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric YH Chen, MD

CONTACT

Chung-Ming Leung, Bsc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 26, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations