SchizophreniaPhase 1NCT00952393
Nicotinic Receptors and Schizophrenia
A Phase 1 study testing Pharmacokinetic in people with Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Pharmacokinetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers: males and females who are incapable of pregnancy
Who cannot join
- Medical illnesses requiring acute treatment
- History of seizures
- Substance abuse including nicotine
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220
About this study
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.
Read the detailed description
3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.
- Conditions
- Schizophrenia
- Being tested
- Pharmacokinetic
- Keywords
- receptors nicotinic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmacokineticDrug
Also called GTS-21
Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic | Other | This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation. Receives: Drug: Pharmacokinetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Levels of Drug
This is the plasma level of the drug as determined by high performance liquid chromatography.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robert Freedman, MD, Principal investigator, VA Eastern Colorado Health Care System, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952393
- Sponsor's protocol ID
- MHBB-005-09S
- Status last verified
- Jan 2016
- First submitted
- 3 Aug 2009
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinic Receptors and Schizophrenia
- ClinicalTrials.gov ID
- NCT00952393
- Acronym / sponsor ID
- MHBB-005-09S
- Conditions
- Schizophrenia
- Keywords
- receptors nicotinic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 5 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.
Detailed description
3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic | Other | Drug: PharmacokineticThis single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers: males and females who are incapable of pregnancy
Key exclusion criteria (3 listed)
- Medical illnesses requiring acute treatment
- History of seizures
- Substance abuse including nicotine
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 |
|---|---|---|
| PharmacokineticAlso: GTS-21Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined | Drug | Pharmacokinetic |
Primary outcome
Blood Levels of Drug
Time frame: 12 hours
This is the plasma level of the drug as determined by high performance liquid chromatography.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
VA Eastern Colorado Health Care System, 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 Pharmacokinetic in people with Schizophrenia, run by VA Office of Research and Development 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 5 Feb 2016. 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. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Levels of Drug (time frame: 12 hours). 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 5 Feb 2016.