Brain imaging of the adenosine A2A receptor in schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia; Mental and Behavioural Disorders

• Registration Number: ISRCTN05808181
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-10
• Study Completion: 2016-03-31
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

All participants:
1. Male 20-55 years old
2. Adequate command of English to understand the information leaflet
3. Capacity to consent to participation in the study
4. Allen?s test showing adequate collateral circulation to the hand
5. Normal blood coagulation test

Healthy volunteers:
1. Eligibility determined by the responsible physician based on a medical evaluation including medical history, physical and psychiatric history

Schizophrenia patients (un-medicated):
1. Confirmation of DSM-V diagnosis for schizophrenia or schizophreniform disorder
2. At least one rating of moderate severity (PANSS =4) on the PANSS positive scale
3. Patients including first episode psychosis who have the capacity to make decisions about their clinical care and have chosen to abstain from antipsychotic medication
4. Patients who have had antipsychotic medication in the past must have voluntarily abstained from antipsychotic medication for at least 6 weeks

Schizophrenia patients (medicated):
1. Confirmation of DSM-V diagnosis for schizophrenia or schizophreniform disorder
2. At least one rating of moderate severity (PANSS =4) on the PANSS positive scale
3. Patients should be clinically stable in a non-acute phase for at least four weeks prior to the screening visit
4. Treatment with stable doses of atypical antipsychotics (except clozapine) for at least 12 weeks

Exclusion Criteria

All participants:
1. Males aged less than 20 years and over 55 years
2. Women of all ages
3. Evidence or history of clinically significant hematological, renal, urinary/prostatic, endocrine, dermatological, pulmonary, psychiatric (except for diagnosis indicated in the inclusion criteria for schizophrenia patients), gastrointestinal, cardiovascular or other heart disease, glaucoma, diabetes, hepatic, neurologic, head trauma or allergic disease (except for untreated, asymptomatic, seasonal allergies at time of dosing), if any, and in the opinion of the recruiting physician will impair the safety of the subject and/or the scientific integrity of the study
4. History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that in the opinion of the investigator puts them at risk
5. Significant history and continuing substance (except nicotine) and alcohol abuse
6. Heavy smokers > 20 cigarettes per day
7. Taking anti-asthmatic medication and any other concurrent medication including mood stabilizers, antidepressant or anti-cholinergic medication the physician may feel is contraindicated for the study
8. Subjects consuming > 500 mg per day of caffeine, which roughly equates to 5 cups of tea or coffee, 8 cans or five 20-ounce bottles of cola
9. Participation in a clinical trial and having received an investigational product within the time period mentioned prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
10. Exposure to more than four investigational new chemical entities within 12 months prior to the study
11. Donation of blood or blood products in excess of 500 ml within any 60-day period prior to the present study
12. Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: no more than 10 mSv in addition to natural background radiation, in the previous 12 months, including the dose from this study)
13. History of, or suffers from, claustrophobia or feels that they will be unable to lie still on their back in the MRI or PET scanner for a period of 2 hours
14. Presence of a cardiac pacemaker or other body implants that are ferromagnetic as assessed by a standard pre-MRI questionnaire

Study & Design

• Study Type: Interventional
• Study Design: Not specified