The Evaluation and Naturalistic Follow-up of Patients With Bipolar Disorder
Collecte de données
Troubles bipolaires et apparentés+5
+ Troubles Mentaux
+ Processus pathologiques
Résumé
Date de début de l'étude : 1 décembre 1996
Date à laquelle le premier participant a commencé l'étude.The purpose of this research protocol is to screen and enroll individuals who have bipolar disorder and to track each person's course of illness in order to study the long-term course of illness and to elucidate possible clinical and biological predictors of acute and sustained treatment response. As a part of this protocol, subjects will: systematically be administered psychiatric rating scales such as the life-chart method (LCM) for daily assessment of mood, sleep, and behavior; be asked to participate in non-invasive research procedures, such as blood drawing for measurement of thyroid antibodies and intracellular calcium; and be medicated as is clinically appropriate. This protocol also serves as a stepping stone to other protocols such as the comparative acute and long-term efficacy of three antidepressants (#95-M-0129), and the efficacy of omega-3 fatty acids (#00-M-0004), for which separate written informed consents are obtained. Patients in this study are participants in the larger NIMH-Stanley Foundation Bipolar Network (SFBN), which involves six academic sites focused on better understanding the long-term course and treatment of the illness. The current protocol thus serves as an entry point for individuals with bipolar disorder for screening and detailed longitudinal assessment both prior to and in between more formal blind randomized IRB approved treatment protocols.
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.150 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 non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Subjects must fulfill DSM-IV criteria for Bipolar I disorder (BPI), Bipolar II disorder (BPII), Bipolar Disorder not otherwise specified (BPNOS), or schizoaffective disorder bipolar type. Subjects must be competent to comprehend the purpose of the study and to provide written informed consent and be willing to participate in detailed longitudinal follow-up. Subjects will undergo complete psychiatric diagnostic interview (SCID--DSM-IV), medical, neurological, and laboratory examinations (as appropriate such as EKG, renal and liver function tests, serum electrolytes, urinalysis, HIV, hepatitis B, pregnancy testing, and urine drug screen for the presence of psychoactive drugs and drugs of abuse). Subjects must be at least 18 years old. Subjects should have no general medical illness that is primary (i.e. appears to be causing the mood disorder), or contraindicates the use of conventional and study medications under other protocols. Women participants of child bearing potential must be nongravid, nonnursing, and using acceptable method of birth control such as intrauterine device, diaphragm with contraceptive foam, or condom with spermicide. Subjects must not have alcohol or substance use or dependence of sufficient magnitude to require independent, concurrent treatment intervention (excluding self-help groups), i.e., hospitalization, day treatment programs, or counselor visits.
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