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

NCT01520649 | Completed Phase 1 DMC

• 1 other identifier: NS-2010-3
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Keywords

Neurogenesis; hippocampal stem cells; depression; stroke

Outcome Measures

Primary Outcomes (1)

• Safety of drug assessed by number and severity of adverse events in drug vs placebo group

  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.

  28 days

Secondary Outcomes (1)

• 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.

  28 days

Study Arms (2)

NSI-189 Phosphate

EXPERIMENTAL

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).

Drug: NSI-189 Phosphate

microcrystalline cellulose capsules

PLACEBO COMPARATOR

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).

Drug: microcrystalline cellulose capsules

Interventions

NSI-189 Phosphate 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).

NSI-189 Phosphate

microcrystalline cellulose capsules 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

Sponsors & Collaborators

• Neuralstem Inc.: lead

Study Sites (1)

California Clinical Trials

Glendale, California, United States

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Depression; Stroke

Interventions

NSI-189; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karl Johe, PhD

  Neuralstem Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: January 30, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 2, 2014

Record last verified: 2012-11

Locations

US (1)