Study Seeking Patients with Major Depressive Disorder (Depression)

  • STATUS
    Recruiting
  • sponsor
    Allergan
Updated on 25 March 2021

Summary

Study Seeking Patients with Major Depressive Disorder (Depression)

Description

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MUTLICENTER STUDY OF RAPASTINEL AS ADJUNCTIVE THERAPY IN MAJOR DEPRESSIVE DISORDER

Details
Clinical Study IdentifierTX148422
SponsorAllergan
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Male or Female 18 to 65 years inclusive
Have DSM 5 Diagnosis of MDD with current MDE of at least 8 weeks and not exceeding 18 months duration
No more than partial response (<50% improvement) to ongoing treatment with a protocol-allowed ADT (US: buproprion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, levomilnacipran, mirtazapine, paroxetine, sertraline, venlafaxine, vilazodone, or vortioxetine, administered at adequate dose per package guidelines and duration not less than 8 weeks

Exclusion Criteria

DSM 5 based diagnosis of any disorder other than MDD that was primary focus of treatment within 6 months before Visit 1. Comorbid GAD, social anxiety, or specific phobias are acceptable as long as secondary to MDD
Lifetime history of meeting DSM 5 criteria for: SCPT or other psychotic disorder, Bipolar or related disorder, neurocognitive disorders, neurodevelopmental disorders, or dissociative disorder
Alcohol or substance use disorder within 6 months prior to Visit 1
Having received anticonvulsant or mood stabilizer within a year prior to Visit 1; OR antipsychotic or ADT augmentation agent at a therapeutic dose and duration in current episode prior to Visit 1
Failure to response to > 3 ADTs
Suicide attempt within past year or significant risk of suicide
Weight less than 40 kg (88 lb) or greater than 125 kg (275lb)
Unstable medical conditions
Hepatitis C, B, or HIV
Clear my responses

How to participate?

Step 1 Connect with a site
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.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note