Topic: Mental Health Research Network
Conditions
Interventions
1. Modafinil. Participants will receive 200mg modafinil on one occasion
2. Placebo: Capsules will be identical to the modafinil capsules, and will contain Lactose
Magnetic resonance imaging (MRI) sca
Study Entry : Single Randomisation only
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 and 35 years 2. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia, schizophreniform or schizoaffective disorder confirmed by Mini International Neuropsychiatric Interview (MINI) 3. Duration of illness between 1 month and 3 years 4. Patients should be clinically stable in a non-acute phase2 for at least 8 weeks prior to the screening visit 5. Positive and Negative Syndrome Scale (PANSS) Conceptual Disorganization item score = 4 6. PANSS Hallucinatory Behaviour or Unusual Thought Content item scores = 4 7. PANSS Negative Subscale scores on all items = 4 8. Treatment with stable doses of atypical or typical antipsychotics in the absence of concomitant anticholinergics for at least 4 weeks prior to the screening visit 9. Normal baseline electrocardiogram (ECG) prior to randomisation 10. Raw score of 6 or greater on the Wechsler Test of Adult Reading (WTAR) 11. Negative result in urine pregnancy test performed during the screening visit in women of childbearing potential (not surgically sterile or 2 years postmenopausal) 12. Women of childbearing 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 12. Subjects must read and write in English at a level sufficient to understand and complete study-related procedures and have legal capacity to consent 13. Written and witnessed informed consent Target Gender: Male & Female; Upper Age Limit 35 years ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. 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 or thioridazine. 3. Treatment with modafinil 4. Current treatment (within 4 weeks) with psychotropic agents known to affect cognition: amphetamines, barbiturates, lithium, 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. Evidence of tardive dyskinesia, tardive dystonia or other severe chronic movement disorders on physical examination 7. History of neuroleptic malignant syndrome 8. Pregnant or breast-feeding women 9. Clinically significant abnormalities on physical examination 10. History of a serious neurological disorder or a systemic illness with known neurological complications 11. Hypertension, arrhythmia, left ventricular hypertrophy, cor pulmonale, or clinically significant signs of CNS stimulant-induced mitral valve prolapse (including ischemic ECG changes, chest pain and arrhythmias), which pose a risk to the patient if they were to participate in the study 12. Any known drug allergies, including sensitivity to modafinil, and the development of drug-associated rash in the past 13. Prior participation in a study of any psychotropic medication or with a neuopsychological component in the last two months preceding the screening visit 14. Unwillingness or inability to follow or comply with the procedures outlined in the protocol 15. Due to the use of the strong magnet, MRI cannot be performed on patients with implanted pacemakers, intracranial aneurysm clips, cochlear implants, certain prosthetic devices, implanted drug infusion pumps, neurostimulators, bone-growth stimulators, certain intrauterine contraceptive devices, or any other type of iron-based metal implants 16. Presence of internal metallic objects such as bullets or shrapnel, as well as surgical clips, pins, plates, screws, metal sutures, or wire mesh 17. Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain activation; Timepoint(s): Mean activation during modafinil compared to placebo during cognitive tasks | — |
Secondary
| Measure | Time frame |
|---|---|
| Task Performance; Timepoint(s): Performance on tasks during modafinil compared to placebo | — |
Countries
United Kingdom
Outcome results
None listed