I-123 Iodobenzamide (IBZM) SPECT Studies of D2 Receptor Distribution and Function in Patients With Schizophrenia and Normal Volunteers
Collecte de données
Synucléinopathies+10
+ Maladies des ganglions de la base
+ Troubles Mentaux
Résumé
Date de début de l'étude : 1 octobre 1991
Date à laquelle le premier participant a commencé l'étude.Abnormalities in dopaminergic neurotransmission have been described in substance abuse and different neuropsychiatric disorders including schizophrenia. \[I-123\] IBZM is a radioligand that has been widely employed for SPECT imaging of dopamine type 2 and type 3 receptors (D2 and D3, respectively) and fluctuations in levels of endogenous dopamine. \[I-123\] IBZM SPECT has been used in the SPECT Lab of the Clinical Brain Disorders Branch for several years without adverse effects. Pharmacological effects of IBZM are unlikely due to the minimal amounts used and have not been observed. We propose to use \[I-123\] IBZM SPECT to explore following questions: 1) Can a previously found relationship between N-acetylaspartate (NAA) measures in the dorsolateral prefrontal cortex and striatal dopamine activity in patients with schizophrenia be replicated and is it also found in normal subjects? 2) Do allelic variants of genes for the dopamine type 2 (DRD2) and type 3 (DRD3) receptors, the dopamine transporter (SLC6A3), or enzymes involved in dopamine biosynthesis (TH) and metabolism (COMT, MAOA) affect D2 receptor availability in vivo? This technical protocol describes the procedural aspects of \[I-123\]IBZM SPECT. It is not intended to be sufficient on its own for a clinical study. All subjects volunteering for this study will be recruited from among individuals who have previously consented to participate in clinical studies under one of two NIH protocols that include genetic testing. Schizophrenia patients will be recruited from among NIMH inpatients participating under NIH protocol #89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients" (Egan 1999a). Normal volunteers will be recruited from among those participating under NIH protocol #95-M-0150, "A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings" (Egan 1999b), which includes recruitment of a normal control group whose first degree relatives are free of mental illness. All details related to clinical care and genetic analysis are contained in those two protocols and their associated consent forms; all details related to \[I-123\]IBZM SPECT studies, per se, are discussed in this protocol, which requires a separate informed consent from each volunteer.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.265 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
INCLUSION CRITERIA: Patients with schizophrenia will be recruited exclusively from among inpatients who are participating in clinical studies of the Clinical Brain Disorders Branch of NIMH under NIH protocol #89-M-0160 (Egan 1999a) and for whom genetic data is already available. Normal volunteers will be recruited exclusively from among individuals who have volunteered for studies under NIH protocol #95-M-0150 (Egan 1999b) as normal control subjects and for whom genetic data is already being analyzed. EXCLUSION CRITERIA: Pregnancy: All women of childbearing age must undergo a pregnancy test prior to injection or radioactive isotope. If the pregnancy test is positive or if the woman has reason to believe she might be pregnant, she will be excluded from this study. Breastfeeding: Women who are breastfeeding will be excluded from this study to avoid unwarranted risk to their children. Iodine sensitivity: Subjects with a prior reaction to iodine, iodine compounds, or shellfish will be excluded from this study. Also, subjects with a history of thyroid disease or dysfunction will be excluded from this study. Substance abuse: Subjects with a history of recent substance abuse will be excluded from this study. Metal objects in body: Subjects with metal objects in their bodies as specified in our MRI protocol (91-M-0124) will be excluded from this study. INCLUSION CRITERIA FOR PATIENTS WITH SCHIZOPHRENIA: Prior participation as a NIMH inpatient under NIH protocol #89-M-0160. Schizophrenia diagnosis according to DSM-IV criteria. EXCLUSION CRITERIA FOR PATIENTS WITH SCHIZOPHRENIA: Coexistence of another mental illness at the time of the study. If the patient has experienced other mental illnesses in the past (e.g. a learning disability or major depression), then this should be judged to be fully recovered. INCLUSION CRITERIA FOR NORMAL CONTROLS: Prior participation as a normal volunteer under NIH protocol #95-M-0150. No Axis I or Axis II diagnoses. EXCLUSION CRITERIA FOR NORMAL CONTROLS: Subjects with an Axis I or II disorder will be excluded. Subjects with concomitant medical or neurological disorders which require ongoing medication, or which may affect the central nervous system will be excluded.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
National Institute of Mental Health (NIMH)
Bethesda, United StatesOuvrir National Institute of Mental Health (NIMH) dans Google Maps