Schizophrenia, Age
Item
Did the male or female subject age 18-65 years, inclusive, meet the diagnostic criteria for schizophrenia as defined in DSM-IV-TR?
boolean
C0036341 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Childbearing potential, Contraception
Item
Is the female eligible to enter and participate in this study?
boolean
C1302261 (UMLS CUI [1,1])
C0086287 (UMLS CUI [1,2])
Symptoms Positive persistent
Item
Did the subject exhibit persistent positive symptoms in each of the 3 months prior to screening as defined by a score of 4 on at least one item of the Brief Psychiatric Rating Scale (BPRS) Psychosis score AND a total score of at least 8 on the BPRS Psychosis score, which consists of the following items: conceptual disorganizaion, hallucinatory behavior, suspiciousness and unusual thought content (items P2, P3, P6 and G9 from the PANSS)?
boolean
C1457887 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
Atypical antipsychotic Specific Quantity
Item
Is the subject continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months with a stable dose for at least 1 month prior to entering the study?
boolean
C1276996 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
CGI-S at least 4
Item
Is the subject’s score on the CGI-S at least 4?
boolean
C3639887 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardian
Item
Is the subject or a legal guardian able to comprehend the key components of the consent form, and able to sign and date a written informed consent form prior to the initiation of any study-related activities?
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Positive and negative syndrome scale Increase Percent | Positive and negative syndrome scale Decrease Percentage
Item
Did the subject’s PANSS total score increase or decrease by more than 20% between the Screening and Baseline visits?
boolean
C0451383 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0451383 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Axis I diagnosis predominant | Schizophrenia
Item
Does the subject have a predominant (i.e., the condition that best and most completely accounts for the current presentation) Axis I disorder other than Schizophrenia within six months prior to screening?
boolean
C0270287 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2])
Disease Clinical Significance Interferes with Clinical Trial | Disease Unstable Interferes with Clinical Trial | Therapeutic procedure Clinical Significance Interferes with Clinical Trial | Therapeutic procedure Unstable Interferes with Clinical Trial
Item
Does the subject have a history of clinically significant or unstable medical disorder including, but not limited to, HIV/AIDS, hepatic, renal, respiratory, cardiovascular endocrinologic, neurologic, hematologic disease, or other disorder or treatment that would interfere with the accurate assessment of safety or efficacy, or interfere with the action, absorption, distribution, metabolism, or excretion of lamotrigine?
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0008976 (UMLS CUI [3,4])
C0087111 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0008976 (UMLS CUI [4,4])
Autistic Disorder | Pervasive Development Disorder | Organic brain disorder | Dementia | Cerebrovascular accident | Epilepsy | Seizures Requirement Therapeutic procedure | Febrile Convulsions | Craniocerebral Trauma
Item
Does the subject have a history of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child) or has the subject suffered a traumatic head injury?
boolean
C0004352 (UMLS CUI [1])
C0524528 (UMLS CUI [2])
C4062280 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0036572 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0087111 (UMLS CUI [7,3])
C0009952 (UMLS CUI [8])
C0018674 (UMLS CUI [9])
Dyskinesia (AIMS), Parkinson's Symptoms (Simpson Angus Scale), Akathisia (Barnes Akathisia Scale)
Item
Does the subject have tardive dyskinesia as defined by the presence of at least moderate (AIMS = 3) abnormal movements in one or more body areas or mild (AIMS = 2) movements in at least two body areas and does the subject have Parkinson’s symptoms as defined by a score greater than 3 on Simpson-Angus, or with symptoms of akathisia greater than mild as defined by the Barnes Akathisia Scale?
boolean
C0450978 (UMLS CUI [1])
C0030569 (UMLS CUI [2,1])
C0450973 (UMLS CUI [2,2])
C3541345 (UMLS CUI [3])
abnormal hematology, blood chemistry, ECG or physical examination
Item
Does the subject have evidence of clinically significant abnormalities in hematology, blood chemistry, ECG or physical examination not resolved by Baseline visit?
boolean
C1332129 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C1623258 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
Psychotropic Drugs | Central Nervous System Agents Primary
Item
Is the subject taking a psychotropic or primarily centrally active medication at screening except for atypical antipsychotic(s) and medications for insomnia, agitation, and extrapyramidal symptoms?
boolean
C0033978 (UMLS CUI [1])
C0007680 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Antidepressive Agents | Mood Stabilizer
Item
Has the subject taken antidepressant medications or mood stabilizers within 1 month of screening?
boolean
C0003289 (UMLS CUI [1])
C2917435 (UMLS CUI [2])
more than 2 atypical antipsychotics
Item
Is the subject taking more than two atypical antipsychotics?
boolean
C1276996 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Substance dependence, positive drug screen
Item
Does the subject have a history of substance (which included alcohol) dependence within 12 months or abuse within 3 months of enrollment, or tested positive for an illicit drug (other than cannabinoids) on a urine analysis administered during the screening process?
boolean
C0038580 (UMLS CUI [1])
C0743300 (UMLS CUI [2])
Prior Treatment with Lamotrigine
Item
Does the subject have a history of treatment with lamotrigine whereby any of the criteria in the description apply?
boolean
C0064636 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Psychotherapy
Item
Has the subject initiated psychotherapy within 3 months prior to the screening visit, or plan to initiate psychotherapy during the trial?
boolean
C0033968 (UMLS CUI [1])
Homicidal or suicidal risk
Item
Does the subject, in the investigator's judgement, pose a current homicidal or serious suicidal risk, has the subject made a suicide attempt within the six months preceding screening or has the subject ever been homicidal?
boolean
C0563664 (UMLS CUI [1])
C0019872 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
Pregnancy test, planning pregnancy
Item
Does the female subject have a positive serum HCG pregnancy test at screening visit or is lactating or planning to become pregnant within 4 months following the screening visit?
boolean
C0240802 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Investigational Medication within 30 days prior to screening
Item
Has the subject taken any other investigational medication within 30 days of screening for this study?
boolean
C2348568 (UMLS CUI [1])