A pilot study of cognitive enhancer and cognitive training combination: testing a therapeutic paradigm for cognitive impairment in schizophrenia
- Conditions
- SchizophreniaMental and Behavioural Disorders
- Registration Number
- ISRCTN60687844
- Lead Sponsor
- King's College London (KCL) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 49
1. Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder confirmed by Mini International Neuropsychiatric Interview (MINI)
2. Age between 18 and 50 years
3. Males and females
4. Duration of illness equal to or greater than one year
5. Patients should be clinically stable in a non-acute phase for at least 8 weeks prior to the screening visit
6. Subjects will meet the following symptom criteria
6.1. Positive and Negative Syndrome Scale (PANSS) Conceptual Disorganization item score less than or equal to 4
6.2. PANSS Hallucinatory Behaviour or Unusual Thought Content item scores less than or equal to 4
6.3. PANSS Negative Subscale scores on all items less than or equal to 4
7. Subjects will meet the following cognitive performance criteria
7.1. Raw score of 6 or greater on the Wechsler Test of Adult Reading (WTAR)
8. Treatment with stable doses of atypical antipsychotics for at least 4 weeks prior to the screening visit
9. Negative result in the urine pregnancy test performed during the screening visit in women of childbearing potential (not surgically sterile or 2 years postmenopausal)
10.Women of child-bearing potential, who are sexually active, will be considered as potential participants if they are using acceptable methods of contraception, which include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected). Women on combined and progestogen-only contraceptives and on contraceptive patches and vaginal rings will be required to use additional contraceptive precautions for the duration of the trial and 4 weeks after stopping taking modafinil for the study purposes because modafinil may reduce the effectiveness of both combined and progestogen-only contraceptives.
11. Subjects must read and write in English at a level sufficient to understand and complete study-related procedures
12. Written and witnessed informed consent
1. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (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
2. Treatment with clozapine
3. Treatment with modafinil
4. Current treatment (within 4 weeks) with psychotropic agents known to affect cognition: amphetamines, barbiturates, lithium, Monoamine Oxidase Inhibitors (MAOIs), methylphenidate, benzodiazepines, anticholinergics
5. 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)
6. Pregnant or breast-feeding women
7. Clinically significant abnormalities on physical examination
8. History of a serious neurological disorder or a systemic illness with known neurological complications
9. Hypertension, arrhythmia, left ventricular hypertrophy, cor pulmonale, or clinically significant signs of central nervous system (CNS) stimulant-induced mitral valve prolapse (including ischaemic electrocardiogram [ECG] changes, chest pain and arrhythmias), which pose a risk to the patient if they were to participate in the study
10. Any known drug allergies, including sensitivity to modafinil, and the development of drug-associated rash in the past
11. Unwillingness or inability to follow or comply with the procedures outlined in the protocol
12. Prior participation in a clinical trial of any psychotropic medication in the last 2 months preceding the screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The effect of the combination of modafinil and cognitive training on learning capacity of the research participants, i.e. the percentage of correct responses and mean response time on the cognitive training tasks as a function of cognitive training, and the effect of the cobmination of modafinil and training on the cognitive outcome measures (MATRICS Consensus Cognitive Battery [MCCB] and CogState)<br> Outcomes will be measured every day during the combined intervention period (Day 2 to Day 11) and also once during the 2nd week of the follow-up period.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Change in the composite scores of the neuropsychological batteries (CogState and MCCB) scores following a single dose of modafinil<br> 2. Reliabillity of CogState and MACCB batteries in the face of repeating testing<br>