SchizophreniaPhase 2/3NCT00222235
Adjunctive Treatment for Decreasing Symptoms of Schizophrenia
A Phase 2/3 study testing d-cycloserine and glycine in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 5 sites in 2 countries.
Trial summary
This study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- d-cycloserine and glycine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2000to Jun 2004
- Phase
- Phase 2/3
- 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 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of schizophrenia or schizoaffective disorder
- stable, enduring negative symptoms above a certain level (SANS >19)
- clinically stable, with psychotic symptoms measured on BPRS below 19, anxiety/depression on BPRS below 15
- extrapyramidal symptoms measured on SAS below 9
- on stable antipsychotic regimen (not including clozapine)
Who cannot join
- alcohol or substance dependence within last six months
- alcohol or substance abuse within last month
- organic brain disorder
- medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus
- Female participants could not be pregnant and were required to be using a documented method of contraception.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Maryland Psychiatric Research Center
Baltimore, Maryland, 21228
Zucker Hillside Hospital
Glen Oaks, New York, 11004
UCLA/VA Greater Los Angeles Health Care System
Los Angeles, California, 90073
Nathan S Kline Institute for Psychiatric Research
Orangeburg, New York, 10982
Israel1 site
Ezrath Nashim Association, Sarah Herzog Memorial Hospital
Jerusalem, 91531
About this study
Official title: Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)
This study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.
Read the detailed description
A double-blind, placebo controlled clinical trial to examine whether adjunctive treatment with glycine or d-cycloserine, compared to placebo, will improve negative symptoms and cognitive impairments in patients with schizophrenia who remain on their normal antipsychotic regimen.
Multicenter, randomized, double-blinded placebo controlled parallel-groups clinical trial designed to test the hypothesis that interventions (glycine or d-cycloserine) intended to increase glutamatergic activity by action at the NMDA receptor will reduce persistant negative symptoms and cognitive impairments of patients with schizophrenia or schizoaffective disorder. After an initial screening phase to establish clinical stability and eligibility, patients were assigned to one of three adjunctive treatments (placebo, d-cycloserine or glycine)for 16 weeks of double-blind treatment. Patients remained on a stable dose of antipsychotic therapy (other than clozapine) throughout the study.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- d-cycloserine, glycine, placebo
- Keywords
- schizophrenia, schizoaffective disorder, negative symptoms, cognitive impairments
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-cycloserineDrug
glycineDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from baseline in negative symptoms measured on SANS at 4,8,12 and 16 weeks.
change from baseline on neurocognitive battery measured at 16 weeks.
Secondary outcomes (2)
change in psychotic and depressive symptoms measured at 4,8,12, and 16 weeks.
changes in extrapyramidal side effects at 4,8,12 and 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2000
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Zucker Hillside Hospital, Nathan Kline Institute for Psychiatric Research, University of California, Los Angeles, Sarah Herzog Hospital, University of Maryland, College Park
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- William T Carpenter, MD, Study chair, Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222235
- Sponsor's protocol ID
- R01MH059807
- Other IDs
- R01MH059807
- Status last verified
- Aug 2019
- First submitted
- 13 Sep 2005
- Last updated
- 20 Aug 2019
- Results posted
- No
Publications
Buchanan RW, Javitt DC, Marder SR, Schooler NR, Gold JM, McMahon RP, Heresco-Levy U, Carpenter WT. The Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST): the efficacy of glutamatergic agents for negative symptoms and cognitive impairments. Am J Psychiatry. 2007 Oct;164(10):1593-602. doi: 10.1176/appi.ajp.2007.06081358.
PubMed 17898352
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)
- ClinicalTrials.gov ID
- NCT00222235
- Acronym / sponsor ID
- R01MH059807
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective disorder, negative symptoms, cognitive impairments
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Zucker Hillside Hospital, Nathan Kline Institute for Psychiatric Research, University of California, Los Angeles, Sarah Herzog Hospital, University of Maryland, College Park
- Study start
- Jan 2000 (actual)
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 22 Sep 2005 (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 will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.
Detailed description
A double-blind, placebo controlled clinical trial to examine whether adjunctive treatment with glycine or d-cycloserine, compared to placebo, will improve negative symptoms and cognitive impairments in patients with schizophrenia who remain on their normal antipsychotic regimen.
Multicenter, randomized, double-blinded placebo controlled parallel-groups clinical trial designed to test the hypothesis that interventions (glycine or d-cycloserine) intended to increase glutamatergic activity by action at the NMDA receptor will reduce persistant negative symptoms and cognitive impairments of patients with schizophrenia or schizoaffective disorder. After an initial screening phase to establish clinical stability and eligibility, patients were assigned to one of three adjunctive treatments (placebo, d-cycloserine or glycine)for 16 weeks of double-blind treatment. Patients remained on a stable dose of antipsychotic therapy (other than clozapine) throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosis of schizophrenia or schizoaffective disorder
- stable, enduring negative symptoms above a certain level (SANS >19)
- clinically stable, with psychotic symptoms measured on BPRS below 19, anxiety/depression on BPRS below 15
- extrapyramidal symptoms measured on SAS below 9
- on stable antipsychotic regimen (not including clozapine)
Key exclusion criteria (5 listed)
- alcohol or substance dependence within last six months
- alcohol or substance abuse within last month
- organic brain disorder
- medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus
- Female participants could not be pregnant and were required to be using a documented method of contraception.
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 |
|---|---|---|
| d-cycloserine | Drug | – |
| glycine | Drug | – |
| placebo | Drug | – |
Primary outcome
changes from baseline in negative symptoms measured on SANS at 4,8,12 and 16 weeks.
change from baseline on neurocognitive battery measured at 16 weeks.
2 secondary outcomes
change in psychotic and depressive symptoms measured at 4,8,12, and 16 weeks.
changes in extrapyramidal side effects at 4,8,12 and 16 weeks.
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 20 Aug 2019.
- Derived from this study: PubMed 17898352Buchanan RW, Javitt DC, Marder SR, Schooler NR, Gold JM, McMahon RP, Heresco-Levy U, Carpenter WT. The Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST): the efficacy of glutamatergic agents for negative symptoms and cognitive impairments. Am J Psychiatry. 2007 Oct;164(10):1593-602. doi: 10.1176/appi.ajp.2007.06081358.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
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.
William T Carpenter, MD study chair
Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicien
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing d-cycloserine and glycine in people with Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 5 sites in 2 countries.
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 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
changes from baseline in negative symptoms measured on SANS at 4,8,12 and 16 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?
On the ClinicalTrials.gov record for NCT00222235, 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 20 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.