Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

Key facts

Study ID

NCT02892422

Run by

H. Lundbeck A/S

People needed

528

Starts

2016-08-01

Expected to finish

2019-10-10

Last updated by the study team

2020-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For 16159A-patients
• The patient has completed Study 16159A.
• The patient is able to read and understand the Informed Consent Form.
• The patient has signed the Informed Consent Form specific for Study 16159B.
• The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
• For 16323A-patients
• The patient has completed the dosing period of Study 16323A.
• The patient is able to read and understand the Informed Consent Form.
• The patient has signed the Informed Consent Form specific Study 16159B.
• The patient has a confirmed diagnosis of schizophrenia according to DSM-5™.
• The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
• For Other Patients
• The patient has schizophrenia, diagnosed according to DSM-5™.
• The patient is a man or woman, aged ≥18 years.
• The patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the Screening Visit.
• The patient has a PANSS total score ≥60 and ≤90 at Screening and Baseline Visits.
• The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4.
• The patient is in need of a change in the current antipsychotic treatment and, according to the investigator's clinical judgement, the patient can potentially benefit from a switch to another treatment including, but not limited to, any of the following reasons:
• lack of adequate response to his or her current antipsychotic medication;
• poor tolerability to his or her current antipsychotic medication;
• unwillingness of the patient to adhere to his or her current antipsychotic medication.

You may not qualify if…

• For 16159A-patients
• The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A.
• The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the Columbia-Suicide Severity Rating Scale (C-SSRS), OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
• For 16323A-patients
• The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A.
• The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
• For Other Patients
• The patient has any current psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis.
• The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
• The patient is treated with clozapine at the time of the Screening Visit.
• The patient has a substance use disorder (except nicotine) which according to the investigator's judgment may compromise the patient's ability to comply with the study procedures, or preclude the benefits of the study medication.
• The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
• Other protocol defined inclusion and exclusion criteria may apply

Where it is running

• US1062 — Costa Mesa, California, United States
• US1463 — Culver City, California, United States
• US1399 — Escondido, California, United States
• US1104 — Garden Grove, California, United States
• US1114 — National City, California, United States
• US1459 — Oceanside, California, United States
• US1368 — Orange, California, United States
• US1391 — San Bernardino, California, United States
• US1392 — Torrance, California, United States
• US1318 — Lauderhill, Florida, United States
• US1130 — Miami, Florida, United States
• US1129 — North Miami, Florida, United States
• US1402 — Oakland Park, Florida, United States
• US1403 — Atlanta, Georgia, United States
• US1009 — Atlanta, Georgia, United States
• US1046 — Chicago, Illinois, United States
• US1423 — Hoffman Estates, Illinois, United States
• US1398 — Shreveport, Louisiana, United States
• US1404 — Shreveport, Louisiana, United States
• US1086 — Flowood, Mississippi, United States
• US1444 — Las Vegas, Nevada, United States
• US1426 — Berlin, New Jersey, United States
• US1244 — Fresh Meadows, New York, United States
• US1394 — New York, New York, United States
• US1018 — Bellflower, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.