SchizophreniaPhase 4NCT00964041
Once Weekly D-cycloserine for Schizophrenia
A Phase 4 study testing D-cycloserine in people with Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 4, \& 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in adult outpatients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- D-cycloserine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2011
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18-65 years
- Diagnosis of schizophrenia or schizoaffective disorder, depressed type
- Stable dose of antipsychotic for at least 4 weeks.
- Able to provide informed consent
- Able to complete a cognitive battery
Who cannot join
- Current treatment with clozapine
- Dementia
- Seizure disorder
- Unstable medical illness
- Active substance abuse
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
- Severe renal insufficiency (Serum creatinine > 1.5 mg/dL)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia.
This is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 4, \& 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in adult outpatients with schizophrenia.
Read the detailed description
In a previous placebo-controlled trial, investigators demonstrated significant improvement of negative symptoms with once-weekly D-cycloserine treatment. In addition, investigators found significant improvement of memory consolidation following the first dose; however, the effect on memory consolidation was lost after several weeks. The "practice effect" of weekly measurement of memory consolidation using repeated administration of the Logical Memory Test may have resulted in a "ceiling effect" which would obscure drug/placebo differences. In the current study, investigators propose to administer the Logical Memory Test at four-week intervals (weeks 1, 4 and 8) to avoid the ceiling effect. Additionally a measurement will be added of negative symptoms at week 4 to better characterize the time course of negative symptom improvement.
Hypotheses:
- Assess the effects of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
- Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 \& 8.
- Assess the effects of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery at week 8 compared to placebo.
- Assess effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 \& 8 compared to placebo.
- Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
- Conditions
- Schizophrenia
- Being tested
- D-cycloserine, Placebo
- Keywords
- Cognitive Impairment, Neuroplasticity, D-cycloserine, N-methyl-D-aspartate (NMDA), Anti-Bacterial Agents, Mental Disorders, Psychotic Disorders, Antitubercular Agents, Schizophrenia and Disorders with Psychotic Features, Schizoaffective Disorder
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction, Mental Disorders, Psychotic Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Also called Seromycin, Cycloserine
50 mg by mouth weekly, one hour before assessments, for eight weeks.
PlaceboDrug
Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| D-cycloserine | Experimental | Participants will receive D-cycloserine weekly, one hour before any assessments, for eight weeks. Receives: Drug: D-cycloserine |
| Placebo | Placebo comparator | Participants will receive placebo weekly, one hour before any assessments, for eight weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery.
Measured: Baseline (Week 0) and End of Study (Week 8)
Secondary outcomes (4)
Effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo.
Measured: Baseline (Week 0) and End of Study (Week 8)
Effect of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
Measured: Same Day (Single Dose - Week 1)
Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8.
Measured: Week 4 and Week 8
Assess tolerability and side effects of weekly D-cycloserine compared to placebo
Measured: Weekly measurements for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionJun 2011
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.
- More trials run by Massachusetts General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Donald C. Goff, MD, Massachusetts General Hospital
- Investigators
- Donald C Goff, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964041
- Sponsor's protocol ID
- 2009-P-001341
- Other IDs
- P50MH060450, DATR A3-NSC
- Status last verified
- Nov 2013
- First submitted
- 20 Aug 2009
- Last updated
- 20 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia.
- ClinicalTrials.gov ID
- NCT00964041
- Acronym / sponsor ID
- 2009-P-001341
- Conditions
- Schizophrenia
- Keywords
- Cognitive Impairment, Neuroplasticity, D-cycloserine, N-methyl-D-aspartate (NMDA), Anti-Bacterial Agents, Mental Disorders, Psychotic Disorders, Antitubercular Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Aug 2009 (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 is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 4, \& 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in adult outpatients with schizophrenia.
Detailed description
In a previous placebo-controlled trial, investigators demonstrated significant improvement of negative symptoms with once-weekly D-cycloserine treatment. In addition, investigators found significant improvement of memory consolidation following the first dose; however, the effect on memory consolidation was lost after several weeks. The "practice effect" of weekly measurement of memory consolidation using repeated administration of the Logical Memory Test may have resulted in a "ceiling effect" which would obscure drug/placebo differences. In the current study, investigators propose to administer the Logical Memory Test at four-week intervals (weeks 1, 4 and 8) to avoid the ceiling effect. Additionally a measurement will be added of negative symptoms at week 4 to better characterize the time course of negative symptom improvement.
Hypotheses:
- Assess the effects of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
- Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 \& 8.
- Assess the effects of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery at week 8 compared to placebo.
- Assess effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 \& 8 compared to placebo.
- Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-cycloserine | Experimental | Drug: D-cycloserineParticipants will receive D-cycloserine weekly, one hour before any assessments, for eight weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo weekly, one hour before any assessments, for eight weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Age 18-65 years
- Diagnosis of schizophrenia or schizoaffective disorder, depressed type
- Stable dose of antipsychotic for at least 4 weeks.
- Able to provide informed consent
Key exclusion criteria (7 listed)
- Current treatment with clozapine
- Dementia
- Seizure disorder
- Unstable medical illness
- Active substance abuse
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-cycloserineAlso: Seromycin, Cycloserine50 mg by mouth weekly, one hour before assessments, for eight weeks. | Drug | D-cycloserine |
| PlaceboPlacebo by mouth, weekly, one hour before any assessments, each week for eight weeks. | Drug | Placebo |
Primary outcome
Effect of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery.
Time frame: Baseline (Week 0) and End of Study (Week 8)
4 secondary outcomes
Effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo.
Time frame: Baseline (Week 0) and End of Study (Week 8)
Effect of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
Time frame: Same Day (Single Dose - Week 1)
Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8.
Time frame: Week 4 and Week 8
Assess tolerability and side effects of weekly D-cycloserine compared to placebo
Time frame: Weekly measurements for 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
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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.
Donald C Goff, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing D-cycloserine in people with Schizophrenia, run by Massachusetts General Hospital 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 6 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: withdrawn, as of the sponsor's last update on 20 Nov 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Effect of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery. (time frame: Baseline (Week 0) and End of Study (Week 8)). 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 20 Nov 2013.