Impaired CognitionPhase 4NCT01490567
A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
A Phase 4 study testing Donepezil in people with Impaired Cognition and Schizophrenia, run by Central South University at 1 site in China.
Trial summary
The objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Impaired Cognition, Schizophrenia
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Jun 2012
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version;
- Between 18 and 40 years of age;
- Duration of the illness must be longer than 2 year;
- Patient's current antipsychotic medication regimen must be stable;
- Must be in a stable living arrangement;
Who cannot join
- Patient has mental retardation or severe organic brain syndromes;
- Treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening;
- Has suicidal attempts or ideation or violent behavior within the last 12 months;
- Patient has a history of alcohol/drug dependence;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Xiaofeng Guo, Doctor, 86-731-85554052, gxfd@sina.com.cn
About this study
Official title: Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
The objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.
Read the detailed description
The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.The trial will be complete in 2012.
- Conditions
- Impaired Cognition, Schizophrenia
- Being tested
- Donepezil, placebo
- Keywords
- Impaired Cognition Schizophrenia
- Medical subject headings
- Cognition Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Donepezil hydrochloride
5 mg/day
placeboDrug
placebo 5mg/d
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally. Receives: Drug: placebo |
| donepezil | Active comparator | Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally. Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment
Measured: 12 weeks
Secondary outcomes (1)
Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired CognitionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaofeng Guo, Central South University
- Investigators
- Xiaofeng Guo, doctor, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490567
- Sponsor's protocol ID
- NSFC30900485
- Other IDs
- 201002003
- Status last verified
- Dec 2011
- First submitted
- 9 Nov 2011
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
- ClinicalTrials.gov ID
- NCT01490567
- Acronym / sponsor ID
- NSFC30900485
- Conditions
- Impaired Cognition, Schizophrenia
- Keywords
- Impaired Cognition Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 13 Dec 2011 (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 objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.
Detailed description
The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.The trial will be complete in 2012.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboSubjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally. |
| donepezil | Active comparator | Drug: DonepezilSubjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DSM-IV diagnosis of schizophrenia as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version;
- Between 18 and 40 years of age;
- Duration of the illness must be longer than 2 year;
- Patient's current antipsychotic medication regimen must be stable;
- Must be in a stable living arrangement;
Key exclusion criteria (4 listed)
- Patient has mental retardation or severe organic brain syndromes;
- Treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening;
- Has suicidal attempts or ideation or violent behavior within the last 12 months;
- Patient has a history of alcohol/drug dependence;
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 |
|---|---|---|
| DonepezilAlso: Donepezil hydrochloride5 mg/day | Drug | donepezil |
| placeboplacebo 5mg/d | Drug | placebo |
Primary outcome
Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment
Time frame: 12 weeks
1 secondary outcome
Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
Related trials for Impaired Cognition
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
the Second Xiangya Hospital of Central South University
Changsha, China
Xiaofeng Guo, doctor principal investigator
Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Impaired Cognition and Schizophrenia, run by Central South University 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 5 inclusion and 4 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 13 Dec 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment (time frame: 12 weeks). 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 13 Dec 2011.