Study Seeking Patients with Depression

  • STATUS
    Recruiting
  • sponsor
    Forest
Updated on 25 March 2021

Summary

Study Seeking Patients with Depression

Description

A MULTICENTER, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED PARALLEL-GROUP EVALUATION OF THE SAFETY AND EFFICACY OF VILAZODONE IN PEDIATRIC PATIENTS WITH MAJOR DEPRESSIVE DISORDER

Details
Condition Depression (Adolescent)
Clinical Study IdentifierTX148436
SponsorForest
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or Female 7-17 years inclusive
Have DSM-IV-TR MDD primary diagnosis confirmed by the MINI for > 6 weeks

Exclusion Criteria

A current (within 3 months of Screening) principal DSM-IV-TR based diagnosis of an Axis-I disorder other than MDD within 6 months before Screening (visit 1) that is the primary focus of treatment
(comorbid diagnoses of learning disorders, ADHD, communication disorders, separation anxiety, ODD, and anxiety disorders are permitted if not the primary focus of treatment and all conmeds/limitations comply.)
Patients with conduct disorder will not be allowed to participate
A prior diagnosis of mental retardation, or amnesic or other cognitive disorders based on DSM-IV-TR criteria
Suicide risk or imminent risk of injuring self or others
Any suicide attempt within the last year
Patients requiring concomitant therapy with any psychotropic drug or any drug with a psychotropic activity that does not comply with the con-meds
History of drug or alcohol abuse or dependence within the past year
Positive UDS for THC, cocaine, methadone or PCP
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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