Schizophrenia Clinical Trial
— DCSOfficial title:
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
Verified date | September 2017 |
Source | Mclean Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the efficacy of d-cycloserine (DCS) as an augmentation
strategy in two psychotic patients with a triplication (4 copies) of the glycine
decarboxylase (GLDC) gene. Subjects will first undergo an eight-week open-label arm of
treatment with DCS (50 mg/d) followed by six 6-week double-blind placebo-controlled exposures
to DCS or placebo. The length of each double-blind arm is limited to six weeks to minimize
the length of symptom exacerbation experienced by the subjects when they are receiving
placebo. The randomization scheme will allow two consecutive exposures to DCS, but will not
allow two consecutive exposures to placebo, again to minimize the length of any symptom
exacerbation. At the end of the open-label DCS trial, the following procedures will be
carried out: structural MRI (3T), proton 1H MRS (4T), fMRI (3T), steady-state auditory evoked
potentials, and electroretinogram recordings. In addition, 1H MRS (4T) for 2 hours after a
single oral dose of a DCS will be assessed. Baseline data on all of these measures were
previously obtained as part of a different study registered in clinical trials.gov -
NCT01720316). Positive, negative, and affective symptoms and neurocognitive function as well
as plasma levels of large neutral and large and small neutral and excitatory amino acids and
psychotropic drug levels will be assessed periodically. Pharmaceutical grade DCS) or placebo
will be compounded and dispensed by the McLean Hospital Pharmacy.
The investigators hypothesize that mutation carriers will have reduced endogenous brain
glycine and GABA levels and increased brain glutamate and glutamine levels. DCS
administration will increase brain glycine in the two carriers compared to baseline and
treatment with glycine (0.8g/kg).
The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs
modulated by NMDA in mutation carriers compared with non-carrier family members and controls.
. The investigators hypothesize that DCS, but not placebo, will improve positive, negative
and affective symptoms as well as neurocognitive function.
The investigators also hypothesize that DCS will improve clinical and cognitive functioning,
will partially normalize decreased baseline glycine and GABA and increased glutamate and
glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked
potentials.
Status | Completed |
Enrollment | 2 |
Est. completion date | July 31, 2017 |
Est. primary completion date | September 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 34 Years to 62 Years |
Eligibility |
Inclusion Criteria: - Carriers of a triplication in the glycine decarboxylase gene Exclusion Criteria: - Not carriers of a triplication in the glycine decarboxylase gene |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital | University of Minnesota - Clinical and Translational Science Institute |
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and Negative Symptom Scores | Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms. | Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2 | |
Primary | Positive and Negative Symptom Scores | Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms. | Baseline, 2, 4, & 6 weeks (crossover periods) | |
Primary | Brief Psychiatric Rating Scale (BPRS) Scores | Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms. | Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2 | |
Primary | Brief Psychiatric Rating Scale (BPRS) Scores | Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms. | Baseline, 2, 4, & 6 weeks (crossover periods) | |
Primary | Clinical Global Impression (CGI) Severity Scores | CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients. | Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2 | |
Primary | Clinical Global Impression (CGI) Severity Scores | CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients. | Baseline, 2, 4, & 6 weeks (crossover periods) | |
Primary | Mania Symptom Scores | Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms. | Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2 | |
Primary | Depression Symptom Scores | Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms. | Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2 | |
Primary | Mania Symptom Scores | Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms. | Baseline, 2, 4, & 6 weeks (crossover periods) | |
Primary | Depression Symptom Scores | Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms. | Baseline, 2, 4, & 6 weeks (crossover periods) | |
Secondary | Neurocognitive Function | Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution, standard deviation of 10. Higher scores signify better functioning. | Baseline and Week 8 of open-label DCS treatment | |
Secondary | Brain Glycine/CR Ratio | Proton magnetic resonance spectroscopy at 4T: brain glycine/CR ratio. Participants were assessed at baseline (pre-glycine challenge dose and 60, 80, 100 and 120 minutes post glycine dose) and in week 8 of of open-label DCS treatment: pre-DCS dose, and 60, 80, 100 and 120 minutes post DCS dose. Measured in posterior occipital cortex. | Baseline and Week 8 of DCS treatment | |
Secondary | Auditory Evoked Potentials in Latency (Msec) | Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz. | Baseline and Week 8 of DCS treatment | |
Secondary | Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) | Auditory evoked potential amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2; mismatch negativity (MMN) at fz and cz. | Baseline and Week 8 of DCS treatment | |
Secondary | Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared) | Auditory evoked potential gamma: G40 hz phase locking at fz and cz; G30 hz phase locking at fz and cz; G20 hz phase locking at fz and cz | Baseline and Week 8 of DCS treatment | |
Secondary | Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude) | Auditory evoked potential amplitude: P50 ratio (P50 S2/S1) | Baseline and Week 8 of DCS treatment |
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