SchizophreniaPhase 4GuanfacineNCT00469664
Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
A Phase 4 study testing Guanfacine/Tenex in people with Schizophrenia and Schizoaffective Disorder, run by Research Foundation for Mental Hygiene, Inc. at 3 sites in United States.
Trial summary
Our overall aim is to determine if the administration of guanfacine in combination with aripiprazole, olanzapine, quetiapine, and/or risperidone is significantly more effective than any of those medications alone in treating some of the cognitive impairment in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Cognitive Impairment
- What is being tested?
- Guanfacine/Tenex
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2000to Dec 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be males and females between the ages of 18 and 55.
- In good general medical health.
- Have a DSMIV diagnosis of schizophrenia, any subtype, or schizoaffective disorder.
- Patients who have been diagnosed with other DSMIV Axis I disorders may be included, unless they are actively using illicit substances.
- Receiving treatment with aripiprazole, olanzapine, quetiapine, and/or risperidone as their antipsychotic medication
- Subjects will demonstrate significant memory impairment by performing at least two standard deviations below normal performance on the California Verbal Learning Test (CVLT). Using subjects with a clear impairment in acquisition and recall will avoid a ceiling effect in this measure.
- Subjects will also be required to have at least an 8th grade reading level and/or a full-scale IQ of at least 85 as assessed by the Wide Range Achievement Test (WRAT).
- Patients are allowed to be on the following anti-depressant medications: Fluoxetine (PROZAC), Sertraline (ZOLOFT), Paroxetine (PAXIL), Celexa (CITALOPRAM), Busprion (WELLBUTRIN), Venlafaxine (EFFEXOR), and Buspirone (BUSPAR).
Who cannot join
- Have a recent history (within previous year) of serious suicide, homicide, or serious physical violence, or current suicidal or homicidal thoughts
- Active use of illicit substances.
- Meet DSM-IV criteria for a current episode of major depression or mania.
- Have a history of severe head trauma, neurological disorder or medical illness which may contribute to the patient's psychiatric symptoms and cognitive impairment.
- Have a medical illness which requires that they take any medication that has CNS activity or which is known to interact with guanfacine (e.g barbiturates, apha-1 antagonists, beta blockers).
- Receive treatment with other concomitant neuroleptics in addition to risperidone or olanzapine.
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- Receive concomitant anticholinergic drugs, or. If the patient receives benzodiazepines, they must be short or intermediate acting (e.g. alprazolam, lorazepam) and they must be held 48 hours prior to cognitive testing. Treatment with mood stabilizers such as lithium and depakote will be allowed for this study. If the patients is receiving treatment with lithium the level must be < 1 meq/l.
- Are unable to give informed consent.
- Have a history of developmental disorder or less than an eighth grade reading level.
- Have a history of bowel obstruction or untreated benign prostatic hypertrophy. Are taking antihypertensive medications of the class of beta-blockers, alpha-1 antagonists, calcium channel blockers, or alpha-2 agonists.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mount Sinai Medical Center
New York, New York, 10029
Bronx VA Medical Center
The Bronx, New York, 10468
Pilgrim Psychiatric Center
W. Brentwood, New York, 11717
About this study
Official title: A Double Blind Placebo Controlled Study of Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
Our overall aim is to determine if the administration of guanfacine in combination with aripiprazole, olanzapine, quetiapine, and/or risperidone is significantly more effective than any of those medications alone in treating some of the cognitive impairment in schizophrenia.
Read the detailed description
The proposed study is a double blind, placebo controlled, parallel designed investigation comparing the effect of one of four atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and/or risperidone), treatment alone to treatment with one of these in addition to treatment with guanfacine to maximum dose of 3.0 mg per day on a cognitive task performance in schizophrenic patients. The study will take place over fourteen weeks. Patients will receive study medication for the last ten weeks of the protocol.
- Being tested
- Guanfacine/Tenex
- Keywords
- Schizophrenia, Schizoaffective, Cognitive Impairment, Cognition, Memory, Attention, Concentration
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guanfacine/TenexDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial Working Memory Test Trail Making Test: Part A and B.
Measured: Baseline, week 6, week 10
Secondary outcomes (1)
RAVLT,Digit Span Distraction Test,CPT450,Verbal Fluency Test, Wisconsin Card Sorting Test,Stroop Interference Test,Letter-Number Sequencing, Extra Pyramidal Symptom Rating Scale(ESRS),Positive And Negative Symptom Scale
Measured: Baseline, week 6, week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startFeb 2000
- Primary completionAug 2008 (estimated)
- Study completionDec 2008 (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.
- 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
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Bronx VA Medical Center, Icahn School of Medicine at Mount Sinai
- Investigators
- Joseph I Friedman, MD, Principal investigator, Pilgrim Psychiatric Center, Mount Sinai Medical Center, Bronx VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469664
- Sponsor's protocol ID
- 00110
- Other IDs
- 99-621
- Acronym
- Guanfacine
- Status last verified
- May 2008
- First submitted
- 2 May 2007
- Last updated
- 21 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Study of Guanfacine Adjunctive Treatment to Atypical Antipsychotics for Cognitive Dysfunction in Schizophrenia
- ClinicalTrials.gov ID
- NCT00469664
- Acronym / sponsor ID
- Guanfacine / 00110
- Keywords
- Schizophrenia, Schizoaffective, Cognitive Impairment, Cognition, Memory, Attention, Concentration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Bronx VA Medical Center, Icahn School of Medicine at Mount Sinai
- Study start
- Feb 2000
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 4 May 2007 (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.
Our overall aim is to determine if the administration of guanfacine in combination with aripiprazole, olanzapine, quetiapine, and/or risperidone is significantly more effective than any of those medications alone in treating some of the cognitive impairment in schizophrenia.
Detailed description
The proposed study is a double blind, placebo controlled, parallel designed investigation comparing the effect of one of four atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and/or risperidone), treatment alone to treatment with one of these in addition to treatment with guanfacine to maximum dose of 3.0 mg per day on a cognitive task performance in schizophrenic patients. The study will take place over fourteen weeks. Patients will receive study medication for the last ten weeks of the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will be males and females between the ages of 18 and 55.
- In good general medical health.
- Have a DSMIV diagnosis of schizophrenia, any subtype, or schizoaffective disorder.
- Patients who have been diagnosed with other DSMIV Axis I disorders may be included, unless they are actively using illicit substances.
- Receiving treatment with aripiprazole, olanzapine, quetiapine, and/or risperidone as their antipsychotic medication
Key exclusion criteria (10 listed)
- Have a recent history (within previous year) of serious suicide, homicide, or serious physical violence, or current suicidal or homicidal thoughts
- Active use of illicit substances.
- Meet DSM-IV criteria for a current episode of major depression or mania.
- Have a history of severe head trauma, neurological disorder or medical illness which may contribute to the patient's psychiatric symptoms and cognitive impairment.
- Have a medical illness which requires that they take any medication that has CNS activity or which is known to interact with guanfacine (e.g barbiturates, apha-1 antagonists, beta blockers).
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 |
|---|---|---|
| Guanfacine/Tenex | Drug | – |
Primary outcome
Spatial Working Memory Test Trail Making Test: Part A and B.
Time frame: Baseline, week 6, week 10
1 secondary outcome
RAVLT,Digit Span Distraction Test,CPT450,Verbal Fluency Test, Wisconsin Card Sorting Test,Stroop Interference Test,Letter-Number Sequencing, Extra Pyramidal Symptom Rating Scale(ESRS),Positive And Negative Symptom Scale
Time frame: Baseline, week 6, week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2008.
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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.
Joseph I Friedman, MD principal investigator
Pilgrim Psychiatric Center, Mount Sinai Medical Center, Bronx VA Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guanfacine/Tenex in people with Schizophrenia and Schizoaffective Disorder, run by Research Foundation for Mental Hygiene, Inc. at 3 sites in United States.
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 8 inclusion and 10 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 21 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial Working Memory Test Trail Making Test: Part A and B. (time frame: Baseline, week 6, week 10). 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 21 May 2008.