Paranoid SchizophreniaPhase 2NCT00506077

MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

A Phase 2 study testing MK0249 in people with Paranoid Schizophrenia, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug MK0249 for the treatment of the 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
What is being tested?: MK0249
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: No sites listed yet
Study dates: Dec 2007to Oct 2008
Phase: Phase 2
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 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
Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the 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
Patient has total Positive and Negative Syndrome Scale (PANSS) score between 36 and 75 at screening and at the first baseline visit
Patient has a Clinical Global Impressions - Severity (CGI-S) score less than or equal to 4 at screening and at the first baseline visit

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 or clozapine 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 the past 5 years
Patient has a history of alcohol or drug dependence within the 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 MK0249 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 MK0249 for the treatment of the cognitive impairment in patients with schizophrenia.

Conditions: Paranoid Schizophrenia
Being tested: MK0249, Comparator: Placebo (unspecified)
Keywords: Undifferentiated schizophrenia, residual schizophrenia
Medical subject headings: Schizophrenia, Paranoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK0249Drug
MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.
Comparator: Placebo (unspecified)Drug
MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.

Study groups in NCT00506077
Study group	Role	What they receive
MK0249	Experimental	Not described Receives: Drug: MK0249
Placebo	Placebo comparator	Not described Receives: 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 in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.
Measured: Baseline and 4 weeks of treatment

Secondary outcomes (3)

Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score
The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.
Measured: Baseline and 4 weeks of treatment
Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score
The Episodic Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.
Measured: Baseline and 4 weeks of treatment
Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score
The Working Memory Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.
Measured: Baseline and 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.

Dec 2007Oct 2008

First posted25 Jul 2007 (estimated)
Study startDec 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.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00506077
Sponsor's protocol ID: 0249-016
Other IDs: 2007_522
Status last verified: Jul 2015
First submitted: 24 Jul 2007
Last updated: 3 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

F Egan M, Zhao X, Gottwald R, Harper-Mozley L, Zhang Y, Snavely D, Lines C, Michelson D. Randomized crossover study of the histamine H3 inverse agonist MK-0249 for the treatment of cognitive impairment in patients with schizophrenia. Schizophr Res. 2013 May;146(1-3):224-30. doi: 10.1016/j.schres.2013.02.030. Epub 2013 Mar 22.
PubMed 23523692

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
Not yet recruitingPhase 2
An Investigation of Mechanisms That Underly Paranoia in Behaviour and Brain That Can Inform Clinical Diagnoses That Include Paranoid Symptoms.
None Volunteer
Recruiting
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Schizophrenia Disorders
Recruiting
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
Delusional Disorder, Brief Psychotic Disorder

All Paranoid Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 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 MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT00506077
Acronym / sponsor ID: 0249-016
Conditions: Paranoid Schizophrenia
Keywords: Undifferentiated schizophrenia, residual schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 25 Jul 2007 (estimated)
Results: Posted 7 Mar 2011

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 MK0249 for the treatment of the 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
MK0249	Experimental	Drug: MK0249
Placebo	Placebo comparator	Drug: Comparator: Placebo (unspecified)

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 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
Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout the 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 or clozapine 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
MK0249MK0249 10mg (2 x 5 mg) tablet daily (qd) for 28 days.	Drug	MK0249
Comparator: Placebo (unspecified)MK0249 10mg (2 x 5 mg) Pbo tablet qd for a 28 day treatment period.	Drug	Placebo

Primary outcome

Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
Time frame: Baseline and 4 weeks of treatment
The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.

3 secondary outcomes

Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score
Time frame: Baseline and 4 weeks of treatment
Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score
Time frame: Baseline and 4 weeks of treatment
Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score
Time frame: Baseline and 4 weeks of treatment

Results and safety

Results posted to the registry on 7 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK0249 Then Placebo	28	24
Placebo Then MK0249	27	24

Primary outcome: Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.

Time frame: Baseline and 4 weeks of treatment. Least squares mean (95% Confidence Interval). Unit: Composite T-score

Measure	MK0249 n = 47	Placebo n = 46
Value	0.4 (-1.2 to 2.1)	0.5 (-1.1 to 2.2)

MK0249 vs Placebo: p = 0.939, constrained longitudinal data analysis

Population analysed: Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were assessed for adverse events (AEs) from visit 2 (V2) (Day -7): Neuropsych Testing through visit 11 (V11) (Day 77): 2-week Follow-Up.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK0249	0 of 52 (0%)	20 of 52 (38.5%)	Not reported
Placebo	0 of 51 (0%)	15 of 51 (29.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23523692F Egan M, Zhao X, Gottwald R, Harper-Mozley L, Zhang Y, Snavely D, Lines C, Michelson D. Randomized crossover study of the histamine H3 inverse agonist MK-0249 for the treatment of cognitive impairment in patients with schizophrenia. Schizophr Res. 2013 May;146(1-3):224-30. doi: 10.1016/j.schres.2013.02.030. Epub 2013 Mar 22.

Related trials for Paranoid Schizophrenia

RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
Not yet recruitingPhase 2
An Investigation of Mechanisms That Underly Paranoia in Behaviour and Brain That Can Inform Clinical Diagnoses That Include Paranoid Symptoms.
None Volunteer
Recruiting
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy
Schizophrenia Disorders
Recruiting
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
Delusional Disorder, Brief Psychotic Disorder

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 MK0249 in people with Paranoid 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 7 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 3 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. 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?

Yes. Results are posted in the registry (first posted 7 Mar 2011). 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?

Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. (time frame: Baseline and 4 weeks of treatment). 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 NCT00506077, 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 3 Aug 2015.