SchizophreniaPhase 1NCT00255918
Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients
A Phase 1 study testing Dimethoxybenzylidene anabaseine (DMXB-A) in people with Schizophrenia and Psychotic Disorders, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in producing beneficial effects similar to that of nicotine in individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- Dimethoxybenzylidene anabaseine (DMXB-A)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Oct 2005
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia
Who cannot join
- History of cardiovascular illness or neurological illness other than schizophrenia
- Current substance abuse, including nicotine
- History of clozapine use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado General Clinical Research Center
Denver, Colorado, 80262
About this study
Official title: Phase 1 Trial of 3-2,4 Dimethoxbenzylidene Anabaseine in Schizophrenia
This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in producing beneficial effects similar to that of nicotine in individuals with schizophrenia.
Read the detailed description
Schizophrenia is a chronic and severe brain disorder that can significantly impact quality of life. It is characterized by delusions, paranoia, and disordered thinking. The cause of schizophrenia has not yet been determined. However, there are many treatments, including drug therapy and cognitive behavioral therapy, that may help to alleviate symptoms of the condition. Nicotinic receptors are involved in a number of biological processes; they are numerous throughout the central and peripheral nervous systems and are diverse in structure and expression. Genetic and neurobiological research has identified decreased expression of the a7 nicotinic receptor as an element in schizophrenia that is related to poor psychosocial outcome. Data indicate that drug therapy may reduce this deficit in receptor expression. Nicotine has been found to stimulate the a7 nicotinic receptor; however, the physiological dependence associated with nicotine makes it an undesirable option. Dimethoxbenzylidene anabaseine (DMXB-A) can stimulate the a7 nicotinic receptor; its advantages include easy oral administration and the lack of dependence-causing effects. This study will determine whether DMXB-A can safely and effectively stimulate the a7 nicotinic receptor in schizophrenia patients and reduce their neurobiological symptoms.
This study will last 6 weeks. Participants will have study visits each week for the duration of the study. During each visit, participants will be randomly assigned to receive either DMXB-A or placebo. An electrocardiogram (EKG) will measure the heart function of participants and participants' blood pressure will be measured. After the first dose of either DMXB-A or placebo, participants will receive a second dose 2 hours later. An evoked potential test, which measures the brain's response to stimuli, will be performed after both doses. Neuropsychological tests, such as verbal reasoning and visual retention, will be performed following the second dose of either DMXB-A or placebo.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- Dimethoxybenzylidene anabaseine (DMXB-A), Placebo
- Keywords
- Evoked Potentials, 3-(2,4-dimethoxybenzylidene)anabaseine, DMXB-A, Receptors, Nicotinic
- 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.
Dimethoxybenzylidene anabaseine (DMXB-A)Drug
DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose
PlaceboDrug
Placebo dosed to match active medication
Dimethoxybenzylidene anabaseine (DMXB-A)Drug
DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose
| Study group | Role | What they receive |
|---|---|---|
| Dimethoxybenzylidene anabaseine 75 mg | Experimental | Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 75 mg) Receives: Drug: Dimethoxybenzylidene anabaseine (DMXB-A); Drug: Placebo |
| Placebo | Placebo comparator | Participants will take placebo. Receives: Drug: Dimethoxybenzylidene anabaseine (DMXB-A); Drug: Placebo |
| Dimethoxybenzylidene anabaseine 150 mg | Experimental | Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 150 mg) Receives: Drug: Dimethoxybenzylidene anabaseine (DMXB-A); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Scale Score for the Repeatable Battery for the Assessment of Neuropsychological Status
ten subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).
Measured: Measured at 2 hours after drug or placebo
Secondary outcomes (2)
Brief Psychiatric Rating Scale
Brief Psychiatric Rating Scale (BPRS) is a rating scale used to measure psychiatric symptoms
Measured: Measured 4 hours after drug or placebo administration
P50 auditory evoked potential test amplitude/conditioning amplitude ratio
The evoked response amplitude measured in mV to the initial auditory stimulus which is compared to the evoked response amplitude which is measured in mV to a second auditory stimulus that occurs 500 ms later.
Measured: Measured 2.5 hours after drug or placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startMar 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Robert Freedman, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255918
- Sponsor's protocol ID
- 03-0857
- Other IDs
- R01MH061412, DNBBS MC-R
- Status last verified
- Jun 2015
- First submitted
- 16 Nov 2005
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin LF, Kem WR, Freedman R. Alpha-7 nicotinic receptor agonists: potential new candidates for the treatment of schizophrenia. Psychopharmacology (Berl). 2004 Jun;174(1):54-64. doi: 10.1007/s00213-003-1750-1. Epub 2004 Feb 19.
PubMed 15205879
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of 3-2,4 Dimethoxbenzylidene Anabaseine in Schizophrenia
- ClinicalTrials.gov ID
- NCT00255918
- Acronym / sponsor ID
- 03-0857
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- Evoked Potentials, 3-(2,4-dimethoxybenzylidene)anabaseine, DMXB-A, Receptors, Nicotinic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 21 Nov 2005 (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.
This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in producing beneficial effects similar to that of nicotine in individuals with schizophrenia.
Detailed description
Schizophrenia is a chronic and severe brain disorder that can significantly impact quality of life. It is characterized by delusions, paranoia, and disordered thinking. The cause of schizophrenia has not yet been determined. However, there are many treatments, including drug therapy and cognitive behavioral therapy, that may help to alleviate symptoms of the condition. Nicotinic receptors are involved in a number of biological processes; they are numerous throughout the central and peripheral nervous systems and are diverse in structure and expression. Genetic and neurobiological research has identified decreased expression of the a7 nicotinic receptor as an element in schizophrenia that is related to poor psychosocial outcome. Data indicate that drug therapy may reduce this deficit in receptor expression. Nicotine has been found to stimulate the a7 nicotinic receptor; however, the physiological dependence associated with nicotine makes it an undesirable option. Dimethoxbenzylidene anabaseine (DMXB-A) can stimulate the a7 nicotinic receptor; its advantages include easy oral administration and the lack of dependence-causing effects. This study will determine whether DMXB-A can safely and effectively stimulate the a7 nicotinic receptor in schizophrenia patients and reduce their neurobiological symptoms.
This study will last 6 weeks. Participants will have study visits each week for the duration of the study. During each visit, participants will be randomly assigned to receive either DMXB-A or placebo. An electrocardiogram (EKG) will measure the heart function of participants and participants' blood pressure will be measured. After the first dose of either DMXB-A or placebo, participants will receive a second dose 2 hours later. An evoked potential test, which measures the brain's response to stimuli, will be performed after both doses. Neuropsychological tests, such as verbal reasoning and visual retention, will be performed following the second dose of either DMXB-A or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dimethoxybenzylidene anabaseine 75 mg | Experimental | Drug: Dimethoxybenzylidene anabaseine (DMXB-A), Drug: PlaceboParticipants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 75 mg) |
| Placebo | Placebo comparator | Drug: Dimethoxybenzylidene anabaseine (DMXB-A), Drug: PlaceboParticipants will take placebo. |
| Dimethoxybenzylidene anabaseine 150 mg | Experimental | Drug: Dimethoxybenzylidene anabaseine (DMXB-A), Drug: PlaceboParticipants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 150 mg) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of schizophrenia
Key exclusion criteria (3 listed)
- History of cardiovascular illness or neurological illness other than schizophrenia
- Current substance abuse, including nicotine
- History of clozapine use
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 |
|---|---|---|
| Dimethoxybenzylidene anabaseine (DMXB-A)DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose | Drug | Dimethoxybenzylidene anabaseine 150 mg, Dimethoxybenzylidene anabaseine 75 mg, Placebo |
| PlaceboPlacebo dosed to match active medication | Drug | Dimethoxybenzylidene anabaseine 150 mg, Dimethoxybenzylidene anabaseine 75 mg, Placebo |
| Dimethoxybenzylidene anabaseine (DMXB-A)DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose | Drug | Dimethoxybenzylidene anabaseine 150 mg, Dimethoxybenzylidene anabaseine 75 mg, Placebo |
Primary outcome
Total Scale Score for the Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: Measured at 2 hours after drug or placebo
ten subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).
2 secondary outcomes
Brief Psychiatric Rating Scale
Time frame: Measured 4 hours after drug or placebo administration
P50 auditory evoked potential test amplitude/conditioning amplitude ratio
Time frame: Measured 2.5 hours after drug or placebo administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Background: PubMed 15205879Martin LF, Kem WR, Freedman R. Alpha-7 nicotinic receptor agonists: potential new candidates for the treatment of schizophrenia. Psychopharmacology (Berl). 2004 Jun;174(1):54-64. doi: 10.1007/s00213-003-1750-1. Epub 2004 Feb 19.
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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.
Robert Freedman, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dimethoxybenzylidene anabaseine (DMXB-A) in people with Schizophrenia and Psychotic Disorders, run by University of Colorado, Denver at 1 site 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 1 Jul 2015. 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Scale Score for the Repeatable Battery for the Assessment of Neuropsychological Status (time frame: Measured at 2 hours after drug or placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00255918, which also lists 1 linked publication.
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 1 Jul 2015.