SchizophreniaPhase 1/2NCT02538081
Nicotinic Receptors and Schizophrenia
A Phase 1/2 study testing Risperidone plus DMXB-A in people with Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study proposes to conduct a clinical trial comparison of olanzapine and the combination of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test the hypothesis that 7-nicotinic receptor… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone plus DMXB-A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2016
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 25
- Diagnosis of schizophrenia or schizoaffective disorder
- 18-75 years of age
- Taking olanzapine at least 10 mg
- If female, willing to use acceptable birth control during the study
- fluent in english
Who cannot join
- No emergent serious medical issues:
- cardiovascular disease
- neurological illnesses including -
- severe head injury
- HIV infection
- liver disease
Show all 12Show fewer
- blood diseases
- kidney disease
- No drugs of abuse
- Not pregnant
- Not able to fast
- History of severe head injury
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
About this study
This study proposes to conduct a clinical trial comparison of olanzapine and the combination of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test the hypothesis that 7-nicotinic receptor agonism may be an additional necessary factor that enhances the efficacy of olanzapine that allows its slight superiority to risperidone. This trial would enroll patients taking olanzapine and record baseline measurements of clinical symptoms, cognition, metabolic parameters, and extrapyramidal side effects. The subjects would then be randomized to receive either risperidone or risperidone plus DMXB-A for 6 weeks and then would again have measurements of clinical symptoms, cognition, metabolic parameters and extrapyramidal side effects.
Read the detailed description
Basic investigations in both animals and humans point to an increase in cholinergic neurotransmission as one possible mechanism of clozapine and olanzapine's enhanced therapeutic effects. However, there has not been a specific clinical trial to determine if stimulation of a nicotinic cholinergic receptor would capture this enhancement and be safer for patients. In the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) those assigned to risperidone from olanzapine had significantly higher discontinuation rates, with the primary reason being lack of efficacy. Olanzapine assignment for all patients was associated with continuing weight gain, which was not seen in patients assigned to risperidone. Many patients assigned to olanzapine from risperidone discontinued because of intolerability of the olanzapine, with metabolic problems being the chief reason. Thus, risperidone is a safer drug and, while equally effective for some patients, for others olanzapine continues to be more effective and tolerated despite its metabolic effect. The baseline rates on entry into the study are typical of most surveys of chronically ill patient populations; about twice as many were receiving olanzapine as were receiving risperidone, which suggests that clinicians choose to treat many patients on olanzapine, despite its side effects, because they do not do well on most other antipsychotic drugs.
This study proposes to conduct a clinical trial comparison of olanzapine and the combination of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test the hypothesis that 7-nicotinic receptor agonism may be an additional necessary factor that enhances the efficacy of olanzapine that allows its slight superiority to risperidone. In pilot data, the investigators studied 11 patients who received DMXB-A 300 mg plus olanzapine 20 mg (n=5) or risperidone 4 mg (n=6). The investigators found that DMXB-A improved performance on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) mean battery score of the risperidone-treated patients to the level of the olanzapine-treated patient.
This trial would enroll patients taking olanzapine and record baseline measurements of clinical symptoms, cognition, metabolic parameters, and extrapyramidal side effects. The subjects would then be randomized to receive either risperidone or risperidone plus DMXB-A for 6 weeks and then would again have measurements of clinical symptoms, cognition, metabolic parameters and extrapyramidal side effects.
- Conditions
- Schizophrenia
- Being tested
- Risperidone plus Placebo, Risperidone plus DMXB-A
- Keywords
- schizophrenia, olanzapine, risperidone, alpha 7 nicotinic receptors, cognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone plus PlaceboDrug
Also called Risperdal
Standard of care including Risperidone plus Placebo
Risperidone plus DMXB-ADrug
Also called Risperdal
Standard of care including Risperidone plus DMXB-A
| Study group | Role | What they receive |
|---|---|---|
| Risperidone plus placebo | Active comparator | Risperidone titrated to a dose equivalency of the patients' prior dose of olanzapine plus placebo Receives: Drug: Risperidone plus Placebo |
| Risperidone plus DMXB-A | Active comparator | Risperidone titrated to a dose equivalency of the patients' prior dose of olanzapine plus DMXB-A Receives: Drug: Risperidone plus DMXB-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Attention due to DMXB-A
the difference in the attention index from the RBANS measured at 6 weeks between risperidone plus DMXB-A and risperidone plus placebo
Measured: measured at 6 weeks
Change in Executive Function due to DMXB-A
the difference in the executive function index from the RBANS measured at 6 weeks between risperidone plus DMXB-A and risperidone plus placebo
Measured: measured at 6 weeks
Secondary outcomes (25)
Change in LDL
the difference in LDL at 6 weeks on risperidone plus placebo or risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in HDL
the difference in HDL measured at 6 weeks between risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in glucose
the difference in glucose measured at 6 weeks on either risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in Hemoglobin A1C
The difference in hemoglobin A1C measured at 6 weeks on either risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in insulin levels
The difference in insulin levels measured at 6 weeks between on either risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in c-reactive protein
The difference in C-reactive protein measured at 6 weeks between risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in girth
The difference in girth measured at 6 weeks between risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in BMI
The difference in BMI measured at 6 weeks between risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in Cholesterol
The difference in Cholesterol measured at 6 weeks between risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 6 weeks
Change in the total scale score of the brief psychiatric rating scale
The difference in the Total scale score of the Brief Psychiatric Rating Scale BPRS measured at 6 weeks or at study conclusion on either risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks of drug administration, or, if the subject exits the study prematurely, on the day of study exit.
Change in the scale for the assessment of negative symptoms
The difference in the clinical Scale for the Measurement of Negative Symptoms (SANS) measured at 6 weeks on either risperidone plus placebo and risperidone plus DMXB-A
Measured: measured at 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Change in Attention index with switch from olanzapine to risperidone plus DMXB-A
The difference in the attention index from the RBANS measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in Executive function index with switch from olanzapine to risperidone plus DMXB-A
The difference in the executive function index from the RBANS measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in Total BPRS with switch from olanzapine to risperidone plus DMXB-A
The difference in the Total BPRS measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in SANS with switch from olanzapine to risperidone plus DMXB-A
The difference in the SANS measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in BMI with switch from olanzapine to risperidone plus DMXB-A
The difference in the BMI measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in c-reactive protein with switch from olanzapine to risperidone plus DMXB-A
The difference in the c-reactive protein measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in LDL with switch from olanzapine to risperidone plus DMXB-A
The difference in the LDL measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in HDL with switch from olanzapine to risperidone plus DMXB-A
The difference in the HDL measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in glucose with switch from olanzapine to risperidone plus DMXB-A
The difference in the glucose measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in cholesterol with switch from olanzapine to risperidone plus DMXB-A
The difference in the cholesterol measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in cholesterol with switch from olanzapine to risperidone plus DMXB-A
The difference cholesterol measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in girth with switch from olanzapine to risperidone plus DMXB-A
The difference girth measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in insulin levels with switch from olanzapine to risperidone plus DMXB-A
The difference insulin levels measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Change in hemoglobin A1C with switch from olanzapine to risperidone plus DMXB-A
The difference in Hemoglobin A1C measured on olanzapine at baseline and at 6 weeks on risperidone plus DMXB-A
Measured: measured at baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Withdrawn
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Robert Freedman, MD, Principal investigator, VA Eastern Colorado Health Care System, Denver, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538081
- Sponsor's protocol ID
- CLNA-008-14S
- Other IDs
- 14-1443
- Status last verified
- May 2017
- First submitted
- 10 Aug 2015
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinic Receptors and Schizophrenia
- ClinicalTrials.gov ID
- NCT02538081
- Acronym / sponsor ID
- CLNA-008-14S
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, olanzapine, risperidone, alpha 7 nicotinic receptors, cognition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Colorado, Denver
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Sep 2015 (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 proposes to conduct a clinical trial comparison of olanzapine and the combination of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test the hypothesis that 7-nicotinic receptor agonism may be an additional necessary factor that enhances the efficacy of olanzapine that allows its slight superiority to risperidone. This trial would enroll patients taking olanzapine and record baseline measurements of clinical symptoms, cognition, metabolic parameters, and extrapyramidal side effects. The subjects would then be randomized to receive either risperidone or risperidone plus DMXB-A for 6 weeks and then would again have measurements of clinical symptoms, cognition, metabolic parameters and extrapyramidal side effects.
Detailed description
Basic investigations in both animals and humans point to an increase in cholinergic neurotransmission as one possible mechanism of clozapine and olanzapine's enhanced therapeutic effects. However, there has not been a specific clinical trial to determine if stimulation of a nicotinic cholinergic receptor would capture this enhancement and be safer for patients. In the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) those assigned to risperidone from olanzapine had significantly higher discontinuation rates, with the primary reason being lack of efficacy. Olanzapine assignment for all patients was associated with continuing weight gain, which was not seen in patients assigned to risperidone. Many patients assigned to olanzapine from risperidone discontinued because of intolerability of the olanzapine, with metabolic problems being the chief reason. Thus, risperidone is a safer drug and, while equally effective for some patients, for others olanzapine continues to be more effective and tolerated despite its metabolic effect. The baseline rates on entry into the study are typical of most surveys of chronically ill patient populations; about twice as many were receiving olanzapine as were receiving risperidone, which suggests that clinicians choose to treat many patients on olanzapine, despite its side effects, because they do not do well on most other antipsychotic drugs.
This study proposes to conduct a clinical trial comparison of olanzapine and the combination of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test the hypothesis that 7-nicotinic receptor agonism may be an additional necessary factor that enhances the efficacy of olanzapine that allows its slight superiority to risperidone. In pilot data, the investigators studied 11 patients who received DMXB-A 300 mg plus olanzapine 20 mg (n=5) or risperidone 4 mg (n=6). The investigators found that DMXB-A improved performance on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) mean battery score of the risperidone-treated patients to the level of the olanzapine-treated patient.
This trial would enroll patients taking olanzapine and record baseline measurements of clinical symptoms, cognition, metabolic parameters, and extrapyramidal side effects. The subjects would then be randomized to receive either risperidone or risperidone plus DMXB-A for 6 weeks and then would again have measurements of clinical symptoms, cognition, metabolic parameters and extrapyramidal side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperidone plus placebo | Active comparator | Drug: Risperidone plus PlaceboRisperidone titrated to a dose equivalency of the patients' prior dose of olanzapine plus placebo |
| Risperidone plus DMXB-A | Active comparator | Drug: Risperidone plus DMXB-ARisperidone titrated to a dose equivalency of the patients' prior dose of olanzapine plus DMXB-A |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI > 25
- Diagnosis of schizophrenia or schizoaffective disorder
- 18-75 years of age
- Taking olanzapine at least 10 mg
- If female, willing to use acceptable birth control during the study
Key exclusion criteria (12 listed)
- No emergent serious medical issues:
- No drugs of abuse
- Not pregnant
- Not able to fast
- History of severe head injury
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 |
|---|---|---|
| Risperidone plus PlaceboAlso: RisperdalStandard of care including Risperidone plus Placebo | Drug | Risperidone plus placebo |
| Risperidone plus DMXB-AAlso: RisperdalStandard of care including Risperidone plus DMXB-A | Drug | Risperidone plus DMXB-A |
Primary outcome
Change in Attention due to DMXB-A
Time frame: measured at 6 weeks
the difference in the attention index from the RBANS measured at 6 weeks between risperidone plus DMXB-A and risperidone plus placebo
Change in Executive Function due to DMXB-A
Time frame: measured at 6 weeks
the difference in the executive function index from the RBANS measured at 6 weeks between risperidone plus DMXB-A and risperidone plus placebo
25 secondary outcomes
Change in LDL
Time frame: measured at 6 weeks
Change in HDL
Time frame: measured at 6 weeks
Change in glucose
Time frame: measured at 6 weeks
Change in Hemoglobin A1C
Time frame: measured at 6 weeks
Change in insulin levels
Time frame: measured at 6 weeks
Change in c-reactive protein
Time frame: measured at 6 weeks
Change in girth
Time frame: measured at 6 weeks
Change in BMI
Time frame: measured at 6 weeks
Change in Cholesterol
Time frame: measured at 6 weeks
Change in the total scale score of the brief psychiatric rating scale
Time frame: measured at 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks of drug administration, or, if the subject exits the study prematurely, on the day of study exit.
Change in the scale for the assessment of negative symptoms
Time frame: measured at 2 weeks, 3 weeks, 4 weeks, 5 weeks and 6 weeks
Change in Attention index with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in Executive function index with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in Total BPRS with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in SANS with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in BMI with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in c-reactive protein with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in LDL with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in HDL with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in glucose with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in cholesterol with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in cholesterol with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in girth with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in insulin levels with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Change in hemoglobin A1C with switch from olanzapine to risperidone plus DMXB-A
Time frame: measured at baseline and 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: No
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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, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Risperidone plus DMXB-A 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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 30 May 2017. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Attention due to DMXB-A (time frame: measured at 6 weeks). 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 30 May 2017.