SchizophreniaPhase 2NCT00063297
Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
A Phase 2 study testing R209130 in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 29 sites in United States.
Trial summary
This study is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- R209130
- How many people
- 180 participants
- Where
- 29 sitesUnited States
- Study dates
- May 2003to Oct 2003
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60
- Current diagnosis of schizophrenia
- Significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
- Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
- Subjects must be able to provide consent
- Must be healthy based on medical exam, laboratory tests and electrocardiogram
Who cannot join
- Female subjects who are either pregnant or nursing.
- Acute or unstable medical conditions
- Diseases of the central nervous system
- Subjects who are judged clinically to be at serious risk for suicide or violence
- Subjects with delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Med Psych Specialists, LLC
Atlanta, Georgia, 30340
Community Clinical Research
Austin, Texas, 78756
NorthCoast Clinical Trials
Beachwood, Ohio, 44122
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35209
IPR
Cerritos, California, 90703
Synergy Clinical Research
Chula Vista, California, 91910
CNS Research Institute
Clementon, New Jersey, 14760
University of Colorado
Denver, Colorado, 80262
Berma Research Group
Hialeah, Florida, 33016
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60194
MedLabs Research of Houston
Houston, Texas, 77057
University Hills Clinical Research
Irving, Texas, 75062
University of Mississippi Medical Center-Dept. of Psychiatry
Jackson, Mississippi, 39216
Optimum Health Services
La Mesa, California, 91942
Neurobehavioral Research
Lawrence, New York, 11559
Milwaukee VA Medical Center
Milwaukee, Wisconsin, 53295
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Segal Institute for Clinical Research
North Miami, Florida, 33161
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, 60181
IPS Research
Oklahoma City, Oklahoma, 73103
Global Research & Consulting
Olean, New York, 14760
Quantum Laboratories
Pompano Beach, Florida, 33064
Sierra Vista Hospital
Sacramento, California, 95823
Clinical Innovations
Santa Ana, California, 92705
Study site
Shreveport, Louisiana, 71101
Bayley Seton Campus-Psychiatric Research Division
Staten Island, New York, 10304
Behavioral Medical Research of Staten Island, P.C.
Staten Island, New York, 10305
Research Strategies
Torrance, California, 90503
Psychiatric Institute of Washington
Washington D.C., District of Columbia, 20016
About this study
This study is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults.
- Conditions
- Schizophrenia
- Being tested
- R209130
- Keywords
- schizophrenia with negative symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R209130Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2003 (estimated)
- Study startMay 2003
- Study completionOct 2003
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.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063297
- Sponsor's protocol ID
- CR004342
- Status last verified
- Dec 2003
- First submitted
- 25 Jun 2003
- Last updated
- 28 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT00063297
- Acronym / sponsor ID
- CR004342
- Conditions
- Schizophrenia
- Keywords
- schizophrenia with negative symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Oct 2003
- First posted
- 26 Jun 2003 (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 is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18-60
- Current diagnosis of schizophrenia
- Significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
- Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
- Subjects must be able to provide consent
Key exclusion criteria (5 listed)
- Female subjects who are either pregnant or nursing.
- Acute or unstable medical conditions
- Diseases of the central nervous system
- Subjects who are judged clinically to be at serious risk for suicide or violence
- Subjects with delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence
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 |
|---|---|---|
| R209130 | Drug | – |
Primary outcome
Not reported in the source record.
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 28 Aug 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R209130 in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 29 sites 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 5 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 28 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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 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.
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 28 Aug 2009.