- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00247637
The Genetic Basis of Inherited Neurologic Deficits in People With Schizophrenia
The Genetics of Endophenotypes and Schizophrenia
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Schizophrenia is a disabling disorder that is associated with specific inheritable neurobiologic deficits. These deficits can cause problems with memory, visual attention, information processing, and other aspects of daily living. Understanding the genetic components of these deficits in people with schizophrenia and their unaffected family members may help uncover the neurobiological basis, risk factors, and heritability of the disease. In addition, the information may serve to create more effective treatments and possibly a cure for the disease. This study will serve to provide information about the genetic basis of known inherited neurobiological deficits in people with schizophrenia. In turn, this may guide further studies on the genetics of schizophrenia.
Participants will attend 2 study visits, each of which will last approximately 4 hours. The first will include blood tests and diagnostic interviews of participating families to evaluate the presence of schizophrenic symptoms. The second study visit will entail four neurocognitive and neurophysiological tests. Participants will first have a pre-pulse inhibition test, which uses electrodes to measure eye blinking. Electrodes will also be placed on participants' head, ears, and around their eyes to measure brain waves. Next, participants will undergo an oculomotor test, during which they will wear glasses fitted with sensors that record eye movement. Participants will then be asked to repeat a list of words, letters, and numbers read by a researcher. Last, participants will undergo a computerized performance test requiring them to watch the computer screen and click a mouse whenever they see a number between 0 and 9. Each study visit will take approximately 4 hours.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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California
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Los Angeles, California, Förenta staterna, 90073
- University Of California Los Angeles
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San Diego, California, Förenta staterna, 92103
- University of California, San Diego
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- University of Colorado Health Sciences Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Harvard University
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New York
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New York, New York, Förenta staterna, 10029
- Mount Sinai School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania
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Washington
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Seattle, Washington, Förenta staterna, 98108
- University of Washington and VA Puget Sound Health Care System
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria for Participating Families:
- Families with at least one member who has schizophrenia
Exclusion Criteria:
- N/A
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
percent inhibition to the 60 msec prepulse, P50 suppression, proportion of correct saccades, d, number correct in the reorder condition, the total recall score
Tidsram: Upon entry to the study
|
The primary outcome measure for each endophenotype is as follows: for prepulse inhibition (PPI) the primary measure is the percent inhibition to the 60 msec prepulse; for P50 suppression it is the difference in amplitude between the test and conditioning stimuli; for antisaccade it is the proportion of correct saccades; for the DS-CPT it is (d') which is based on correct target detections and incorrect responses to nontargets; for LNS it is the number correct in the reorder condition; for CVLT it is the total recall score summed across 5 trials.
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Upon entry to the study
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studierektor: David Braff, MD, University of California, San Diego
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R01MH065571 (U.S.S. NIH-anslag/kontrakt)
- DNBBS 7G-GRR
- R01MH065707 (U.S.S. NIH-anslag/kontrakt)
- R01MH065578 (U.S.S. NIH-anslag/kontrakt)
- R01MH065588 (U.S.S. NIH-anslag/kontrakt)
- R01MH065554 (U.S.S. NIH-anslag/kontrakt)
- R01MH065562 (U.S.S. NIH-anslag/kontrakt)
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