D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia
A Placebo-controlled Trial of D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia
3 other identifiers
interventional
54
1 country
1
Brief Summary
This study seeks to examine the effects of D-cycloserine augmentation on cognitive remediation for patients diagnosed with schizophrenia. We will test the hypotheses that D-cycloserine will significantly improve cognitive performance, negative symptoms, and measures of functioning compared to placebo when combined with eight weeks of cognitive remediation. We expect that these effects will persist when assessed at six-month follow up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
August 20, 2014
CompletedFebruary 6, 2018
January 1, 2018
1.7 years
August 20, 2009
June 23, 2014
January 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Change of a composite score from baseline to week 8 on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS). The MATRICS consists of 10 cognitive tasks that are used to calculate scores in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores on each cognitive task are transformed on a normative scale into t-scores, and then these scores are combined to calculate the domain scores. The composite score is calculated by averaging all domain t-scores to come up with one overall cognitive composite t-score. For all scores on the assessment, the higher the score the better the performance on the task.
Baseline vs. Week 8
Scale for Assessment of Negative Symptoms (SANS)
The total scores from baseline and week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. Scores are reported for baseline and week 8.
Baseline vs. Week 8
Auditory Discrimination Task: Interstimulus Interval (ISI)
The auditory discrimination task involved trials in which the subject differentiated between rapidly-presented frequency-modulated sweeps separated by a short interstimulus interval (ISI). In this task, sustained successful performance is more difficult with shorter stimulus presentations and ISIs (which were equal within a trial). Thus, our dependent measure was the shortest stimulus duration/ISI, in ms, for trials in which subjects were able to perform the task at 85% accuracy, referred to as ISI for simplicity. The shorter the score the better the performance on the task. Scores are reported for baseline and week 8.
Baseline vs. Week 8
Secondary Outcomes (6)
Positive and Negative Syndrome Scale (PANSS)
Baseline
Global Assessment of Functioning Scale (GAS)
Baseline
Heinrich Quality of Life Scale (QoL)
Baseline
Calgary Depression Scale for Schizophrenia (CDSS)
Baseline
Clinical Global Impression (CGI)
Weeks 0 and 8, and Month 6 after cognitive remediation completion
- +1 more secondary outcomes
Study Arms (2)
D-cycloserine
EXPERIMENTALParticipants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Placebo
PLACEBO COMPARATORParticipants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
Interventions
50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.
Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.
40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks.
Eligibility Criteria
You may qualify if:
- 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
- Able to perform the cognitive remediation exercises
You may not qualify if:
- Current treatment with clozapine
- Dementia
- Seizure disorder
- Unstable medical illness
- Renal insufficiency measured as eGFR \>60mg/dL/min
- Active substance abuse: positive urine toxic screen
- Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Cain CK, McCue M, Bello I, Creedon T, Tang DI, Laska E, Goff DC. d-Cycloserine augmentation of cognitive remediation in schizophrenia. Schizophr Res. 2014 Mar;153(1-3):177-83. doi: 10.1016/j.schres.2014.01.016. Epub 2014 Jan 30.
PMID: 24485587RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Donald C Goff
- Organization
- Nathan Klein Institute for Psychiatric Research
Study Officials
- PRINCIPAL INVESTIGATOR
Donald C. Goff, M.D.
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Schizophrenia Clinical and Research Program
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 24, 2009
Study Start
August 1, 2009
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
February 6, 2018
Results First Posted
August 20, 2014
Record last verified: 2018-01