Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia
Pilot Study of Pretreatment D-cycloserine for CBT-assessment of Paranoid Delusions in Schizophrenia
3 other identifiers
interventional
21
1 country
1
Brief Summary
This study will examine whether pretreatment with D-cycloserine before cognitive behavioral therapy can reduce impairments still present in people with stable cases of schizophrenia as well as determine which traits make schizophrenics most likely to respond to D-cycloserine treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 schizophrenia
Started Sep 2006
Longer than P75 for phase_4 schizophrenia
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
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
September 5, 2014
CompletedDecember 19, 2017
September 1, 2014
3.8 years
August 25, 2008
August 11, 2014
November 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Alternative Beliefs Assessment
Number of alternative beliefs generated on the Alternative Beliefs Assessment. This assessment used nine vignettes describing social interactions: three of neutral content, three negatively-valanced, and three tailored to the patient's specific delusions. Participants were asked to generate as many explanations (alternative beliefs) as they could for each scenario, and the number of explanations produced in response to each item was recorded. Scores could range from 0 to as many explanations a person could produce (no maximum value). The total score was calculated by adding all alternative beliefs generated from each vignette. A higher number of alternative beliefs generated reflects a greater degree of cognitive flexibility.
Baseline to Week 2
Secondary Outcomes (4)
Change in Psychotic Rating Scales (PSYRATS) Delusion Score
Baseline to Week 2
Change in Beck Cognitive Insight Scale (BCIS)
Baseline to Week 2
Change in Bead Task Score Measuring Probabilistic Reasoning
Baseline to Week 2
Change in the Maudsley Assessment of Delusions Scale
Baseline to Week 2
Study Arms (2)
1 D-cycloserine, placebo
EXPERIMENTALParticipants will receive D-cycloserine 1 hour before a cognitive behavioral therapy (CBT) session on Week 1, and they will receive placebo 1 hour before a CBT session on Week 2.
2 Placebo, D-cycloserine
EXPERIMENTALParticipants will receive placebo 1 hour before a CBT session on Week 1, and they will receive D-cycloserine 1 hour before a CBT session on Week 2.
Interventions
Single, fixed 50-mg dose of D-cycloserine administered 1 hour prior to a CBT session
One-hour talk therapy session with a trained clinician aimed at increasing cognitive flexibility by examining alternative explanations to everyday situations
Eligibility Criteria
You may qualify if:
- Meets DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophrenia, paranoid subtype, based on chart review, Structured Clinical Interview for DSM-IV, and consultation with the patient's clinicians
- Medicated with an antipsychotic agent other than clozapine at a stable dose for at least 6 weeks
- Scores at least 3, or "moderate," on the Scale for the Assessment of Positive Symptoms global delusion rating
- Paranoid or referential delusional content
- Never engaged in formal CBT psychotherapy in the past
You may not qualify if:
- Diagnosis of a comorbid Axis I disorder other than schizophrenia
- Active substance abuse or dependence within 6 months
- Significant suicidal ideation within 6 weeks
- Pregnant or nursing
- Unstable medical disorder
- impaired renal clearance (creatinine \<60mg/dL/min)
- Suffering from dementia
- Suffering from seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MGH Schizophrenia Program - Freedom Trail Clinic
Boston, Massachusetts, 02114, United States
Related Publications (1)
Gottlieb JD, Cather C, Shanahan M, Creedon T, Macklin EA, Goff DC. D-cycloserine facilitation of cognitive behavioral therapy for delusions in schizophrenia. Schizophr Res. 2011 Sep;131(1-3):69-74. doi: 10.1016/j.schres.2011.05.029. Epub 2011 Jun 30.
PMID: 21723096RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The cross-over design of this study produced results that are difficult to interpret due to a significant order effect. Larger and longer trials are needed to assess whether this treatment may benefit patients with medication resistant delusions.
Results Point of Contact
- Title
- Jennifer Gottlieb, PhD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Donald C. Goff, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Schizophrenia Clinical and Research Program
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 27, 2008
Study Start
September 1, 2006
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
December 19, 2017
Results First Posted
September 5, 2014
Record last verified: 2014-09