Study Summary
This trial will use magnetic resonance spectroscopy to study the levels of glutamate and - aminobutyric acid in the brains of people with early-stage schizophrenia, in order to develop better biomarkers for treatment response.
Eligible Conditions
- Schizophrenia
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
4 Primary · 9 Secondary · Reporting Duration: Treatment week 1, treatment week 2, treatment week 3
Week 4
Change in biomarkers of treatment response: Dorsal Caudate (DCA) GABA levels
Baseline and 4th week of of treatment
Changes in neurocognitive performance: MATRICS Consensus Cognitive Battery (MCCB)
Baseline and 4th week of treatment
Change in biomarkers of treatment response: Dorsal Caudate (DCA) Glutamate
Change in biomarkers reflecting treatment response: Medial Prefrontal Cortex (MPFC) GABA
Change in biomarkers reflecting treatment response: Medial Prefrontal Cortex (MPFC) Glutamate
Changes in everyday functioning: University of California San Diego (UCSD) Performance-based Skills Assessment (UPSA)
Day 1
Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire
Day 1
Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale
Participants' Verbal I.Q as Assessed by the WTAR to Determine Clinical Eligibility
Week 3
Changes in clinical symptomatology: Positive and Negative Syndrome Scale (PANSS)
Changes in global functioning: Global Assessment of Functioning (GAF)
Changes in motor symptomatology: Abnormal Involuntary Movement Scale (AIMS)
Week 3
Changes in clinical severity: Clinical Global Impression Scale
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Control
1 of 2
Patient
1 of 2
Active Control
Experimental Treatment
90 Total Participants · 2 Treatment Groups
Primary Treatment: Risperidone · No Placebo Group · Phase 4
Patient
Drug
Experimental Group · 1 Intervention: Risperidone · Intervention Types: DrugControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risperidone
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: treatment week 1, treatment week 2, treatment week 3
Who is running the clinical trial?
Columbia UniversityOTHER
1,295 Previous Clinical Trials
1,613,181 Total Patients Enrolled
19 Trials studying Schizophrenia
1,841 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,552 Previous Clinical Trials
1,823,407 Total Patients Enrolled
228 Trials studying Schizophrenia
87,464 Patients Enrolled for Schizophrenia
Weill Medical College of Cornell UniversityLead Sponsor
986 Previous Clinical Trials
1,338,415 Total Patients Enrolled
6 Trials studying Schizophrenia
224 Patients Enrolled for Schizophrenia
New York State Psychiatric InstituteOTHER
457 Previous Clinical Trials
148,579 Total Patients Enrolled
30 Trials studying Schizophrenia
85,487 Patients Enrolled for Schizophrenia
Dikoma C. Shungu, Ph.D.Principal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
145 Total Patients Enrolled
Eligibility Criteria
Age 18 - 35 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have the capacity to give informed consent.\n
You are between the ages of 18-35.\n
You are free of antipsychotic medications for at least 3 weeks.
You have a diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder.
References
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- Fusar-Poli, Paolo, Stefan Borgwardt, Andreas Bechdolf, Jean Addington, Anita Riecher-Rössler, Frauke Schultze-Lutter, Matcheri Keshavan, et al.. 2013. “The Psychosis High-risk State”. JAMA Psychiatry. American Medical Association (AMA). doi:10.1001/jamapsychiatry.2013.269.
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- Krystal JH, Karper LP, Seibyl JP, Freeman GK, Delaney R, Bremner JD, Heninger GR, Bowers MB Jr, Charney DS. Subanesthetic effects of the noncompetitive NMDA antagonist, ketamine, in humans. Psychotomimetic, perceptual, cognitive, and neuroendocrine responses. Arch Gen Psychiatry. 1994 Mar;51(3):199-214. doi: 10.1001/archpsyc.1994.03950030035004.
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- Perkins DO, Gu H, Boteva K, Lieberman JA. Relationship between duration of untreated psychosis and outcome in first-episode schizophrenia: a critical review and meta-analysis. Am J Psychiatry. 2005 Oct;162(10):1785-804. doi: 10.1176/appi.ajp.162.10.1785.
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- Javitt DC, Zukin SR. Recent advances in the phencyclidine model of schizophrenia. Am J Psychiatry. 1991 Oct;148(10):1301-8. doi: 10.1176/ajp.148.10.1301.
- Laruelle M, Abi-Dargham A. Dopamine as the wind of the psychotic fire: new evidence from brain imaging studies. J Psychopharmacol. 1999 Dec;13(4):358-71. doi: 10.1177/026988119901300405.
- Coyle JT. The glutamatergic dysfunction hypothesis for schizophrenia. Harv Rev Psychiatry. 1996 Jan-Feb;3(5):241-53. doi: 10.3109/10673229609017192.
- Lodge DJ, Grace AA. Aberrant hippocampal activity underlies the dopamine dysregulation in an animal model of schizophrenia. J Neurosci. 2007 Oct 17;27(42):11424-30. doi: 10.1523/JNEUROSCI.2847-07.2007.
- Davis KL, Kahn RS, Ko G, Davidson M. Dopamine in schizophrenia: a review and reconceptualization. Am J Psychiatry. 1991 Nov;148(11):1474-86. doi: 10.1176/ajp.148.11.1474.
- Laruelle M, Abi-Dargham A, van Dyck CH, Gil R, D'Souza CD, Erdos J, McCance E, Rosenblatt W, Fingado C, Zoghbi SS, Baldwin RM, Seibyl JP, Krystal JH, Charney DS, Innis RB. Single photon emission computerized tomography imaging of amphetamine-induced dopamine release in drug-free schizophrenic subjects. Proc Natl Acad Sci U S A. 1996 Aug 20;93(17):9235-40. doi: 10.1073/pnas.93.17.9235.
- 2017. "Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03323437.
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