SchizophreniaNCT01563016
Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia
A study testing glucose drink in people with Schizophrenia, run by The University of Hong Kong at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- glucose drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia: A Randomized Controlled Study
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.
- Conditions
- Schizophrenia
- Being tested
- glucose drink
- Keywords
- schizophrenia, Psychotic Disorders, Psychoses
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose drinkDietary supplement
participants will receive a drink rich in glucose
| Study group | Role | What they receive |
|---|---|---|
| Glucose & Depleting | Experimental | participants will perform in a depleting task and receive a glucose drink Receives: Dietary Supplement: glucose drink |
| Glucose & non-depleting | Placebo comparator | participants will perform in a non-depleting task and receive a glucose drink Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Level
Measured: baseline, after depleting task
self control tasks (handgrip, stroop, figure tracing task)
Measured: after 12-minutes metabolizing phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Eric YH Chen, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563016
- Sponsor's protocol ID
- selfcontrolvsglucose
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2012
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose as a Mediator of Self-control Performances in Patients With Schizophrenia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01563016
- Acronym / sponsor ID
- selfcontrolvsglucose
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, Psychotic Disorders, Psychoses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glucose & Depleting | Experimental | Dietary Supplement: glucose drinkparticipants will perform in a depleting task and receive a glucose drink |
| Glucose & non-depleting | Placebo comparator | Dietary Supplement: glucose drinkparticipants will perform in a non-depleting task and receive a 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Organic Brain disorder
- Known history of intellectual disability
- Priority Follow Up (Subtarget or Target)
- All allergic to any sugar or artificial sweeteners
- Diabetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucose drinkparticipants will receive a drink rich in glucose | Dietary supplement | Glucose & Depleting, Glucose & non-depleting |
Primary outcome
Blood Glucose Level
Time frame: baseline, after depleting task
self control tasks (handgrip, stroop, figure tracing task)
Time frame: after 12-minutes metabolizing phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric YH Chen, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose drink in people with Schizophrenia, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric YH Chen, MD (852-22553063, eyhchen@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Level (time frame: baseline, after depleting task). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.