Study Seeking Patients with Schizophrenia

  • STATUS
    Recruiting
  • sponsor
    Lundbeck
Updated on 25 March 2021

Summary

Study Seeking Patients with Schizophrenia

Description

Interventional, randomized, double-blind, active-controlled, fixed-dose study of Lu AF35700 in patients with treatment-resistant schizophrenia

Details
Condition Schizophrenia and Schizoaffective Disorders, Mental Disability, Psychosis
Clinical Study IdentifierTX148338
SponsorLundbeck
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged ≥ 18 years
Have DSM 5 Diagnosis of Schizophrenia and currently on an antipsychotic at a stable therapeutic dose for 6 weeks prior to screening
Subject has had NO adequate response to an antipsychotic in the past 2 years
Subject has at least a moderate level of symptoms at screening and Baseline 1 (PANSS ≥ 80, CGI ≥ 4)
Subjects must have an informant and stable living situation

Exclusion Criteria

Subject is experiencing an acute exacerbation of psychotic symptoms
Subject has had satisfactory symptom relief due to an antipsychotic in the past 2 years
Current or history of a substance use disorder in the past 6 months (except mild alcohol or mild cannabis use disorder)
Positive UDS except THC
Hepatitis or HIV/AIDS
Active suicidal ideation and/or behavior in the past 3 months
Treatment-resistant to Clozapine
Previous clinical trial participation within 30 days of screening
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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