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

NCT ID: NCT01520649

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-02-28

Brief Summary

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

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

NSI-189 Phosphate

Intervention Type: DRUG

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).

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).

Group Type: PLACEBO_COMPARATOR

microcrystalline cellulose capsules

Intervention Type: DRUG

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).

Interventions

NSI-189 Phosphate

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Eligibility Criteria

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:

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuralstem Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Johe, PhD

Role: STUDY_DIRECTOR

Neuralstem Inc.

Locations

California Clinical Trials

Glendale, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

NS-2010-3

Identifier Type: -

Identifier Source: org_study_id