Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:2/24/2018
Start Date:December 2014
End Date:February 2016

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Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating D1 Dopamine, D2 Dopamine, and 5-HT6 Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700 in Male Patients With Schizophrenia

The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral
dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.


Inclusion Criteria:

1. The patient is a man aged between ≤18 and ≥60 years

2. BMI of ≥19 kg/m2 to ≤ 37 kg/m2

3. The patient has a primary diagnosis of schizophrenia according to DSM-5™ (code 295.90)

4. The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤ 4
(moderately ill) at screening and safety baseline

5. The patient is currently under oral therapy with one or more of the antipsychotic
medications listed in Appendix II.

6. The patient has a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80

7. The patient has a score of ≤ 4 (moderate) on the following PANSS items at screening
and at safety baseline: P7 (hostility), G8 (uncooperativeness)

Exclusion Criteria:

1. The patient experienced an acute exacerbation requiring hospitalization within the
last 3 months.

2. The patient experienced an acute exacerbation requiring change in antipsychotic
medication (with reference to drug or dose) within the last 4 weeks.

3. The patient has a diagnosis or history of substance use disorder (except nicotine)
according to DSM-5-TR® criteria ≤3 months prior to screening

4. The patient is at significant risk of harming himself or others according to the
investigator's judgment or as indicated by an answer of "yes" to the question 4 or 5
on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Screening Visit within
the last six months on the lifetime version of C-SSRS.

5. Based on investigators judgment the patient has a medical or neurological disorder or
treatment for such disorder that could interfere with the study treatment or impair
treatment compliance.

6. The patient has had past episodes of extrapyramidal symptoms (EPS) under current
medication within the last 6 month

7. The patient takes other medication than those listed as allowed concomitant medication
in Appendix III

8. The patient is occupationally exposed to significant levels of ionizing radiation.

Other protocol-defined inclusion and exclusion criteria may apply
We found this trial at
1
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Rockville, Maryland 20850
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Rockville, MD
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