Multiple-Dose Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects



Status:Completed
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:5/3/2014
Start Date:May 2012
End Date:January 2014
Contact:Lev G. Gertsik, MD
Phone:888-228-7425

Use our guide to learn which trials are right for you!

A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects

This is a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation in
depressed human subjects study.


Inclusion Criteria:

1. Patient has the ability to understand the purpose and risks of the study and to
provide signed and dated informed consent, authorizing to use of protected health
information in accordance with national and local patient privacy regulations.

2. Males and females 18 to 60 years of age, inclusive, at the time of informed consent.

3. Diagnosis of major depressive disorder, recurrent, as per DSM-IV-TR criteria and
confirmed by SCID-CT. Their major depressive episode must be confirmed via SCID mood
module interview administered by remote, independent raters.

Note: Both patients who are being treated with antidepressants and patients who are
not on antidepressants but had a history of taking antidepressants are permitted in
the study.

4. Montgomery-Asberg Depression Scale (MADRS) score of 15 to 30, inclusive, at Screening
and baseline.

5. The following applies to female patients:Non-pregnant, non-lactating females of
childbearing potential who agree to use medically acceptable forms of birth control
(hormonal contraception, abstinence, diaphragm with spermicide, condom with
spermicide, or intrauterine device) from Screening until the end-of-study.

6. The following applies to male subjects:
We found this trial at
1
site
Glendale, California 91206
1968
mi
from 43215
Glendale, CA
Click here to add this to my saved trials