Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The University of Texas Health Science Center at San Antonio
With
AstraZeneca
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female;
Age 18 years and older
Patients on:
* Li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5 mEq/l OR
* DIV dose for 4 weeks or longer, and a serum level at screening of 45 g/ml OR
* LAM (dosage/day ≥100mg) at a stable dose for 4 weeks or longer OR
* Any combination 3a, 3b, or 3c
Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score\>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score\>/=14
Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score\>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score\>/=14 ;
Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score\>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score\>/=14
You may not be if
Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or AIDS induced mania
Women with a positive pregnancy test or who are lactating
Women of child-bearing potential who are not practicing a clinically accepted method of contraception
Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
Patients whose clinical status requires inpatient or day hospital treatment
History of severe side effects associated with therapeutic doses of Li, DIV, LAM