EUCTR2009-013020-23-GB
Active, not recruiting
Phase 1
A Pilot study of cognitive enhancer and cognitive training combination – Testing a therapeutic paradigm for cognitive impairment in schizophrenia - ModCTCoS
ConditionsCognitive impairment associated with schizophreniaMedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsProvigil
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cognitive impairment associated with schizophrenia
- Sponsor
- King's College London
- Enrollment
- 49
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •DSM\-IV diagnosis of schizophrenia or schizoaffective disorder confirmed by Mini International Neuropsychiatric Interview (MINI)
- •Age between 18 and 60 years
- •Gender: Males and Females
- •Normal baseline electrocardiogram (ECG)
- •Duration of illness equal to or greater than one year
- •Patients should be clinically stable in a non\-acute phase for at least 8 weeks prior to the screening visit
- •Subjects will meet the following symptom criteria
- •Positive and Negative Syndrome Scale (PANSS) Conceptual Disorganization item score \= 4
- •PANSS Hallucinatory Behaviour or Unusual Thought Content item scores \= 4
- •PANSS Negative Subscale scores on all items \= 4
Exclusion Criteria
- •DSM\-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM\-IV diagnosis of alcohol or substance dependence (other than nicotine) in the last 6 months preceding the screening visit
- •Treatment with clozapine
- •Treatment with modafinil
- •Current treatment (within 4 weeks) with psychotropic agents known to affect cognition: amphetamines, barbiturates, lithium, MAOIs, methylphenidate, benzodiazepines, anticholinergics
- •Current treatment (within 4 weeks) with cyclosporine (modafinil reduces plasma concentration of cyclosporine), phenytoin (modafinil possibly increases plasma concentration of phenytoin), anticoagulants (modafinil increases the levels of anticoagulants), tricyclic antidepressants (modafinil may increase their levels)
- •Evidence of tardive dyskinesia, tardive dystonia or other severe
- •chronic movement disorders on physical examination
- •History of neuroleptic malignant syndrome
- •Pregnant or breast\-feeding women
- •Clinically significant abnormalities on physical examination
Outcomes
Primary Outcomes
Not specified
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