SchizophreniaPhase 2P50NCT00725855
A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients
A Phase 2 study testing MEM 3454 in people with Schizophrenia, run by Memory Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- MEM 3454
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2009
- Phase
- Phase 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Male or female subjects between 18and 55 years of age.
- 2. Fluent in English, even if English is not the primary language.
- 3. Able to provide informed consent.
- 4. DSM IV-R primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (SCID CT).
- 5. Few or no extra-pyramidal symptoms(EPS)at screening,defined as SAS < 6.
- 6. Negative urine drug screen (UDS).
- 7. Negative cotinine test.
- 8. Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. At least one month on the same dose of antipsychotic medication.
Who cannot join
- Current risk of suicide, or history of suicidal behavior within the last 6 months.
- Hospitalized for psychiatric symptoms in the past 3 months.
- Other psychiatric diagnoses.
- Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according to the SCID-CT.
- Currently smoking, nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).
- Any medical condition, as judged by the Investigator, which may interfere with the subjects' participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Ann Olincy, MD, 303-315-5046, ann.olincy@uchsc.edu
Ann Olincy, MD
About this study
Official title: A Single-Center, Double-Blind, Placebo-Controlled, Randomized Blocks Study Investigating the Effect of 4 Dosages (1 mg, 5 mg, 15 mg, 50 mg) of MEM 3454 on P50 Sensory Gating and Mismatch Negativity (MMN) in Patients With Schizophrenia
The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio.
Data produced in this study will provide useful information regarding the value of P50 as an efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional P50 studies.
- Conditions
- Schizophrenia
- Being tested
- MEM 3454, Placebo for MEM 3454
- Keywords
- Schizophrenia, P50 Sensory Gating, Mismatched Negativity
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEM 3454Drug
1 mg dose
MEM 3454Drug
5 mg dose
MEM 3454Drug
15 mg dose
MEM 3454Drug
50 mg dose
Placebo for MEM 3454Drug
Placebo dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1 mg dose Receives: Drug: MEM 3454 |
| 2 | Experimental | 5 mg dose Receives: Drug: MEM 3454 |
| 3 | Experimental | 15 mg dose Receives: Drug: MEM 3454 |
| 4 | Experimental | 50 mg dose Receives: Drug: MEM 3454 |
| 5 | Placebo comparator | Placebo dose Receives: Drug: Placebo for MEM 3454 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454.
Measured: Pre-dosing and Day 1
Secondary outcomes (2)
• Investigate the safety and tolerability of MEM 3454 compared with placebo
Measured: all time points
• Determine whether MMN correlates with P50.
Measured: Pre-dose and day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memory Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Investigators
- Ann Olincy, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725855
- Sponsor's protocol ID
- MEM 3454-102
- Acronym
- P50
- Status last verified
- Jul 2008
- First submitted
- 29 Jul 2008
- Last updated
- 31 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Braff DL, Light GA, Swerdlow NR. Prepulse inhibition and P50 suppression are both deficient but not correlated in schizophrenia patients. Biol Psychiatry. 2007 May 15;61(10):1204-7. doi: 10.1016/j.biopsych.2006.08.015. Epub 2006 Dec 8.
PubMed 17161386Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.
PubMed 16754836Simosky JK, Stevens KE, Freedman R. Nicotinic agonists and psychosis. Curr Drug Targets CNS Neurol Disord. 2002 Apr;1(2):149-62. doi: 10.2174/1568007024606168.
PubMed 12769624
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Blind, Placebo-Controlled, Randomized Blocks Study Investigating the Effect of 4 Dosages (1 mg, 5 mg, 15 mg, 50 mg) of MEM 3454 on P50 Sensory Gating and Mismatch Negativity (MMN) in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00725855
- Acronym / sponsor ID
- P50 / MEM 3454-102
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, P50 Sensory Gating, Mismatched Negativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Memory PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 31 Jul 2008 (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 purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio.
Data produced in this study will provide useful information regarding the value of P50 as an efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional P50 studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEM 34541 mg dose |
| 2 | Experimental | Drug: MEM 34545 mg dose |
| 3 | Experimental | Drug: MEM 345415 mg dose |
| 4 | Experimental | Drug: MEM 345450 mg dose |
| 5 | Placebo comparator | Drug: Placebo for MEM 3454Placebo dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 1. Male or female subjects between 18and 55 years of age.
- 2. Fluent in English, even if English is not the primary language.
- 3. Able to provide informed consent.
- 4. DSM IV-R primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (SCID CT).
- 5. Few or no extra-pyramidal symptoms(EPS)at screening,defined as SAS < 6.
Key exclusion criteria (6 listed)
- Current risk of suicide, or history of suicidal behavior within the last 6 months.
- Hospitalized for psychiatric symptoms in the past 3 months.
- Other psychiatric diagnoses.
- Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according to the SCID-CT.
- Currently smoking, nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).
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 |
|---|---|---|
| MEM 34541 mg dose | Drug | 1 |
| MEM 34545 mg dose | Drug | 2 |
| MEM 345415 mg dose | Drug | 3 |
| MEM 345450 mg dose | Drug | 4 |
| Placebo for MEM 3454Placebo dose | Drug | 5 |
Primary outcome
Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454.
Time frame: Pre-dosing and Day 1
2 secondary outcomes
• Investigate the safety and tolerability of MEM 3454 compared with placebo
Time frame: all time points
• Determine whether MMN correlates with P50.
Time frame: Pre-dose and day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2008.
- Background: PubMed 17161386Braff DL, Light GA, Swerdlow NR. Prepulse inhibition and P50 suppression are both deficient but not correlated in schizophrenia patients. Biol Psychiatry. 2007 May 15;61(10):1204-7. doi: 10.1016/j.biopsych.2006.08.015. Epub 2006 Dec 8.
- Background: PubMed 16754836Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.
- Background: PubMed 12769624Simosky JK, Stevens KE, Freedman R. Nicotinic agonists and psychosis. Curr Drug Targets CNS Neurol Disord. 2002 Apr;1(2):149-62. doi: 10.2174/1568007024606168.
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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.
Ann Olincy, MD, MPH 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 2 study testing MEM 3454 in people with Schizophrenia, run by Memory Pharmaceuticals 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 8 inclusion and 6 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 31 Jul 2008. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann Olincy, MD, (303-315-5046, ann.olincy@uchsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454. (time frame: Pre-dosing and Day 1). 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 NCT00725855, which also lists 3 linked publications.
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 31 Jul 2008.