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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02901587
Other study ID # 16323A
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2016
Est. completion date April 18, 2018

Study information

Verified date September 2019
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date April 18, 2018
Est. primary completion date April 18, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria:

- The patient is able by her/himself to provide informed consent to participate in the study

- The patient has a primary diagnosis of schizophrenia or schizoaffective disorder (DSM-5™ criteria)

- The patient has BMI =35 kg/m2

- The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score =4 (moderately ill)

- PANSS total score = 80 and a score =4 (moderate) on the PANSS items, P7 (hostility) and G8 (uncooperativeness)

- The patient is willing to be hospitalized for up to 8 weeks

- The patient is generally healthy based on medical history, physical examination, vital signs, ECG, and laboratory tests.

- The patient agrees to protocol-defined use of effective contraception

Exclusion Criteria:´

- The patient experienced acute exacerbation of psychosis requiring hospitalization within the last 3 months or required change in medication due to exacerbation of psychosis within the last 8 weeks

- The patient has met moderate or severe co-morbid Substance Abuse Disorder DSM-5™ criteria in the last 3 months

- The patient is at significant risk of harming her/himself or others in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS)

- The patient has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)

Other protocol defined inclusion and exclusion criteria may apply

Study Design


Intervention

Drug:
Lu AF35700 (10 mg/day)
tablets for oral administration once daily
Lu AF35700 (30 mg/day)
tablets for oral administration once daily
Quetiapine (Seroquel XR® 800 mg/day)
tablets for oral administration once daily

Locations

Country Name City State
United States US1104 Long Beach California

Sponsors (1)

Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from time-matched baseline on day 1, 21, and 42 in QTcF Before dose to 10 hours post dose
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