Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

Key facts

Study ID

NCT02717195

Run by

H. Lundbeck A/S

People needed

1098

Starts

2016-04-01

Expected to finish

2018-10-08

Last updated by the study team

2019-11-25

Who can join

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

You may qualify if…

• The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders
• The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist.
• Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening
• The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s)
• The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A)
• The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A

You may not qualify if…

• The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI)
• The patient is experiencing an acute exacerbation of his/her psychotic symptoms
• The patient has not responded to treatment with clozapine
• Other protocol defined inclusion and exclusion criteria may apply

Where it is running

• US1041 — Cerritos, California, United States
• US1062 — Costa Mesa, California, United States
• US1463 — Culver City, California, United States
• US1104 — Garden Grove, California, United States
• US1118 — Glendale, California, United States
• US1114 — National City, California, United States
• US1452 — Oceanside, California, United States
• US1459 — Oceanside, California, United States
• US1399 — Orange, California, United States
• US1368 — Orange, California, United States
• US1391 — San Bernardino, California, United States
• US1464 — Santa Ana, California, United States
• US1384 — Sherman Oaks, California, United States
• US1392 — Torrance, California, United States
• US1396 — Washington D.C., District of Columbia, United States
• US1395 — Bradenton, Florida, United States
• US1253 — Jacksonville, Florida, United States
• US1130 — Miami, Florida, United States
• US1318 — North Miami, Florida, United States
• US1129 — North Miami, Florida, United States
• US1402 — Oakland Park, Florida, United States
• US1229 — Orange City, Florida, United States
• US1453 — Tampa, Florida, United States
• US1403 — Atlanta, Georgia, United States
• US1018 — Bellflower, California, United States

Full record on ClinicalTrials.gov

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