- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01520649
Multiple-Dose Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Glendale, California, United States
- California Clinical Trials
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Males and females 18 to 60 years of age, inclusive, at the time of informed consent.
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.
- Montgomery-Asberg Depression Scale (MADRS) score of 15 to 30, inclusive, at Screening and baseline.
- 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.
- The following applies to male subjects:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NSI-189 Phosphate
There will be 3 ascending cohorts.
The first cohort will be administered 40 mg once daily (q.d).
The second cohort will be administered 40 mg twice daily (b.i.d).
The third cohort will be administered 40 mg three times daily (t.i.d).
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The first cohort will be administered 40 mg once daily (q.d).
The second cohort will be administered 40 mg twice daily (b.i.d).
The third cohort will be administered 40 mg three times daily (t.i.d).
|
Placebo Comparator: microcrystalline cellulose capsules
The first cohort will be administered 40 mg once daily (q.d).
The second cohort will be administered 40 mg twice daily (b.i.d).
The third cohort will be administered 40 mg three times daily (t.i.d).
|
The first cohort will be administered 40 mg once daily (q.d).
The second cohort will be administered 40 mg twice daily (b.i.d).
The third cohort will be administered 40 mg three times daily (t.i.d).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of drug assessed by number and severity of adverse events in drug vs placebo group
Time Frame: 28 days
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Values for vital signs, standard physical examination, ECG, EEG, standard clinical laboratory tests (hematology and biochemistry), standard neurological exam and the Columbia Suicide Severity Rating Scale will be compared between NSI 189 and placebo.
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of NSI 189 will be determined by plasma sample collection at various timepoints pre, during and post dosing, measuring the concentration of drug over time.
Time Frame: 28 days
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Concentration of NSI 189 will be measured in plasma and standard pK values will be determined:AUC, Cmax, Tmax, T1/2, CL, Vz.
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28 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Karl Johe, PhD, Neuralstem Inc.
Publications and helpful links
General Publications
- Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE,Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. PubMed PMID: 12813115. Deng W, Aimone JB, Gage FH. New neurons and new memories: how does adult hippocampal neurogenesis affect learning and memory? Nat Rev Neurosci. 2010 May;11(5):339-50. Epub 2010 Mar 31. Review. PubMed PMID: 20354534; PubMed Central PMCID: PMC2886712. DeCarolis NA, Eisch AJ. Hippocampal neurogenesis as a target for the treatment of mental illness: a critical evaluation. Neuropharmacology. 2010 May;58(6):884-93. Epub 2010 Jan 6. Review. PubMed PMID: 20060007; PubMed Central PMCID: PMC2839019. Marlatt MW, Lucassen PJ. Neurogenesis and Alzheimer's disease: Biology and pathophysiology in mice and men. Curr Alzheimer Res. 2010 Mar;7(2):113-25. Review.PubMed PMID: 19860727. Kernie SG, Parent JM. Forebrain neurogenesis after focal Ischemic and traumatic brain injury. Neurobiol Dis. 2010 Feb;37(2):267-74. Epub 2009 Nov 10. Review. PubMed PMID:19909815; PubMed Central PMCID: PMC2864918. Kempermann G, Krebs J, Fabel K. The contribution of failing adult hippocampalneurogenesis to psychiatric disorders. Curr Opin Psychiatry. 2008;21(3):290-5. PMID:18382230.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NS-2010-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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