Paranoid SchizophreniaPhase 2NCT00482430
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)
A Phase 2 study testing MK0557 in people with Paranoid Schizophrenia and Schizophrenia, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of cognitive impairment in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Paranoid Schizophrenia, Schizophrenia
- What is being tested?
- MK0557
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Oct 2008
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
- Patient has a 6th grade reading level or better and has completed at least 6 years of formal education
- Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout study
- Patient has had a stable living arrangement for at least 3 months prior to study start
- Patient is in general good health based on screening assessments
Who cannot join
- Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
- Patient has a history of head trauma with loss of consciousness greater than 15 minutes
- Patient has had warfarin treatment, MAO inhibitors, clonazepam, clozapine or St. John's wort within 1 month of screening
- Patient has had ECT treatment within 6 months of screening
- Patient requires treatment with antihistamines or certain other medications listed in the protocol
- Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within past 5 years
- Patient has a history of alcohol or drug dependence within past year or alcohol or drug abuse within 3 months of screening
About this study
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia
The purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of cognitive impairment in patients with schizophrenia.
- Conditions
- Paranoid Schizophrenia, Schizophrenia
- Being tested
- MK0557, Comparator: Placebo (unspecified)
- Keywords
- Undifferentiated schizophrenia, Residual schizophrenia
- Medical subject headings
- Schizophrenia, Paranoid, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0557Drug
MK0557 10mg tablet qd for a 15-wk treatment period
Comparator: Placebo (unspecified)Drug
MK0557 Pbo tablet qd for a 15-wk treatment period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd. Receives: Drug: MK0557; Drug: Comparator: Placebo (unspecified) |
| 2 | Other | MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd. Receives: Drug: MK0557; Drug: Comparator: Placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated
Measured: at 4 weeks of treatment
Secondary outcomes (1)
Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory
Measured: at 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paranoid SchizophreniaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482430
- Sponsor's protocol ID
- 0557-027
- Other IDs
- MK0557-027, 2007_520
- Status last verified
- Aug 2015
- First submitted
- 31 May 2007
- Last updated
- 21 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00482430
- Acronym / sponsor ID
- 0557-027
- Conditions
- Paranoid Schizophrenia, Schizophrenia
- Keywords
- Undifferentiated schizophrenia, Residual schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Jun 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.
The purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of cognitive impairment in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: MK0557, Drug: Comparator: Placebo (unspecified)MK0557 10mg tablet qd, crossing over to MK0557 Pbo tablet qd. |
| 2 | Other | Drug: MK0557, Drug: Comparator: Placebo (unspecified)MK0557 Pbo tablet qd, crossing over to MK0557 10mg tablet qd. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
- Patient has a 6th grade reading level or better and has completed at least 6 years of formal education
- Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout study
- Patient has had a stable living arrangement for at least 3 months prior to study start
- Patient is in general good health based on screening assessments
Key exclusion criteria (7 listed)
- Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
- Patient has a history of head trauma with loss of consciousness greater than 15 minutes
- Patient has had warfarin treatment, MAO inhibitors, clonazepam, clozapine or St. John's wort within 1 month of screening
- Patient has had ECT treatment within 6 months of screening
- Patient requires treatment with antihistamines or certain other medications listed in the protocol
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 |
|---|---|---|
| MK0557MK0557 10mg tablet qd for a 15-wk treatment period | Drug | 1, 2 |
| Comparator: Placebo (unspecified)MK0557 Pbo tablet qd for a 15-wk treatment period | Drug | 1, 2 |
Primary outcome
Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated
Time frame: at 4 weeks of treatment
1 secondary outcome
Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory
Time frame: at 4 weeks of treatment
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 21 Aug 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK0557 in people with Paranoid Schizophrenia and Schizophrenia, run by Merck Sharp & Dohme LLC.
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 5 inclusion and 7 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 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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 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?
Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated (time frame: at 4 weeks of treatment). 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 Aug 2015.