Trial record 2 of 7 for:    Neuralstem

Study of NSI-189 for Major Depressive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Neuralstem Inc.
Sponsor:
Information provided by (Responsible Party):
Neuralstem Inc.
ClinicalTrials.gov Identifier:
NCT02695472
First received: February 15, 2016
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
The study will consist of a screening period and a randomized treatment. Approximately 220 subjects who meet eligibility during the screening period will be randomized to initiate a 12-week, double-blind treatment with NSI-189 80 milligrams/day (provided as 40 milligrams twice per day), NSI-189 40 milligrams once a day, or placebo.

Condition Intervention Phase
Major Depressive Disorder
Drug: 80 Milligrams NSI-189
Drug: Placebo
Drug: 40 Milligrams NSI-189
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo-Controlled Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder

Further study details as provided by Neuralstem Inc.:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of Depression Questionnaire (SDQ) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • 17-item Hamilton Rating Scale for Depression (HAMD17) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Cogstate Brief Battery [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    A computerized battery used to measure psychomotor, attention, learning and working memory performance. The subject results are compared with normative data from a population with similar age and gender.

  • CogScreen [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    A computerized battery focused on measures of attention, concentration, information processing, memory span, and working memory. The subject results are compared with normative data from a population with similar age and gender.


Estimated Enrollment: 220
Study Start Date: March 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Arm
One Placebo tablet, twice daily
Drug: Placebo
Orally administered
Experimental: 40 Milligrams NSI-189, total dose daily
One 40 Milligrams NSI-189 tablet and 1 placebo tablet per day
Drug: Placebo
Orally administered
Drug: 40 Milligrams NSI-189
Orally Administered
Other Name: NSI-189 Once a day (QD)
Experimental: 80 Milligrams NSI-189, total dose daily
One 40 Milligrams NSI-189 tablet twice per day
Drug: 80 Milligrams NSI-189
Orally Administered
Other Name: NSI-189 twice per day (BID)

Detailed Description:

The screening period will range from a minimum of 14 days to a maximum of 28 days. The Investigators will determine that the subjects meet eligibility criteria and will collect the demographic and medical data permitting full characterization of the subject.

The duration of the randomization period will be 12 weeks. Subjects who meet inclusion/exclusion criteria at the Baseline Visit will be randomized to NSI-189 80 milligrams/day, given as 40 milligrams twice per day, NSI-189 40 milligrams/day, given once a day, or placebo. The treatment will be double-blinded.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has the ability to understand the purpose, potential benefits and risks of the study and to provide signed and dated informed consent, authorizing the use of protected health information in accordance with national and local Subject 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 Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria and confirmed by Structured Clinical Interview for the Diagnostic and Statistical Manual specific for Clinical Trials. Their major depressive episode must be at least 8 weeks in duration and confirmed via Structured Clinical Interview for the Diagnostic and Statistical Manual mood module interview administered by a remote, independent raters, prior to the baseline visit.
  4. Montgomery-Asberg Depression Scale (MADRS) score of 20 or greater, at Screening and Baseline (MADRS score confirmed to be 20 or greater via remote SAFER interview by an independent rater prior to the baseline visit).
  5. The following applies to female Subjects: Non-pregnant, non-lactating females of childbearing potential are eligible as long as they agree to use a double barrier method of birth control from Screening until 3 months following discontinuation of IP. Women who are not of childbearing potential (bilateral oophorectomy, bilateral tubal ligation, hysterectomy, or post-menopausal for at least 1 year) will not require such parameters in order to be eligible.
  6. The following applies to male subjects: Male subjects with a female partner of childbearing potential will be required to use double barrier method of birth control or practice abstinence during this study and for 3 months following discontinuation of Investigational Product. Note: These requirements also apply for male subjects who have had a vasectomy.
  7. Body mass index (BMI) ≥19.5 and ≤38.0 kg/m2, at Screening. Bodyweight must be >50 kg.
  8. Of stable medical health, in the opinion of the Site Investigator, as determined by Investigator discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory assessments).

Exclusion Criteria:

  1. Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or other major disease as determined by the Investigator or designee such that participation in the study would place subjects at increased risk for serious adverse events.
  2. History of cancer or malignancy within the last 5 years. Note: Subjects with basal or squamous cell carcinoma may be permitted into the study on a case by case basis.
  3. History of seizures; head trauma; or any clinically significant finding on the neurologic examination such that participation in the study would place subjects at increased risk for serious adverse events.
  4. Previous or current diagnosis of bipolar or schizoaffective disorder or psychotic disorder, or any psychotic symptoms during the current major depressive episode (according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition).
  5. Subjects who have a concurrent primary psychiatric diagnosis, diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th edition, other than depression.
  6. Subjects with delirium, dementia, Parkinson's disease, or Huntington's disease.
  7. Subjects who have failed to respond to more than two antidepressant trials of adequate dose (as defined in Massachusetts General Hospital Antidepressant Treatment Response) and duration (at least 8 weeks in duration) during the current major depressive episode as determined by the local rater and confirmed by an independent, remote rater prior to the baseline visit.
  8. Subjects with clinically significant suicidal ideation and/or behavior currently as determined by the Site Investigator, such that participation in the study would place subjects at increased risk for serious adverse events.
  9. Subjects with any current homicidal ideation.
  10. Clinically significant abnormal clinical chemistry values, as determined by the Site Investigator, or any values for Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin or creatinine that are 1.5 times above the upper limit of normal (ULN) and deemed clinically significant by the Site Investigator; any clinically significant values as determined by the Site Investigator for platelets or hemoglobin that are below the lower limit of normal (LLN); or any out of normal range values for white blood cells (WBC) deemed clinically significant by the Site Investigator.
  11. Clinically significant (as determined by the Investigator) 12-lead Electrocardiogram (ECG) abnormalities, including corrected QT interval using Bazett's correction method of >450 msec for males and >470 msec for females.
  12. Subjects with (current) severe Post-Traumatic Stress Disorder (PTSD), severe Obsessive Compulsive Disorder (OCD), severe binge eating disorder, or subjects with anorexia or bulimia nervosa active within the past three years.
  13. Subjects who plan to undergo elective invasive procedures/surgeries at any time during the study through End-of-study.
  14. Subjects taking excluded medications (See Appendix 1)..
  15. History of alcohol or drug-dependence or abuse by Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria and confirmed by Structured Clinical Interview for the Diagnostic and Statistical Manual specific for Clinical Trials within 12 months prior to Screening.
  16. Positive screening test or baseline test for drugs-of-abuse (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, phencyclidine). Note any positive test result(s) for benzodiazepine(s), opiates, or psychostimulants accompanied by confirmation of a prescription for a valid medical reason will be allowed.
  17. Positive serum β-human chorionic gonadotropin (β-HCG) test at Screening or positive urine pregnancy test at baseline that is consistent with pregnancy (females only).
  18. Donation or loss of whole blood >200 mL within 30 days prior to dosing or ≥500 mL within 56 days prior to dosing. Note: Blood taken for routine medical evaluations totaling less than 50 mL will be permitted.
  19. Females who are pregnant, lactating, or planning to become pregnant during the study.
  20. Does not tolerate venipuncture.
  21. Subjects who have had electroconvulsive therapy within the 6 months prior to Screening.
  22. Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an Investigational Product or approved therapy for investigational use within 45 days (or 5 half-lives, whichever is longer) prior to Day 1 of Investigational Product administration.
  23. Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the clinical study.
  24. Subject who, in the opinion of the Site Investigator, are unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.
  25. Subject who, in the opinion of the Site Investigator, are unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up and improbability of completing the clinical study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02695472

Contacts
Contact: Karl Johe, Ph.D. NSI-189MDD@neuralstem.com

Locations
United States, California
Collaborative Neuroscience Network, LLC Recruiting
Garden Grove, California, United States, 92845
Contact: Kathleen Catabay    866-787-4257    kathleencatabay@cnstrial.com   
Contact: David Walling, PhD    866-787-4257    davidwalling@cnstrial.com   
Principal Investigator: David Walling, PhD         
Synergy San Diego Recruiting
National City, California, United States, 91950
Contact: Earle Bartolome    619-327-0155    bartolomee@synergysandiego.com   
Contact: Corey Weise    619-303-6130    weisec@synergyeastinc.com   
Principal Investigator: Mohammed Bari, MD         
United States, Colorado
Clinical Trials of the Rockies Recruiting
Denver, Colorado, United States, 80209
Contact: Bernadette Sullivan    303-482-1296    research@ctorockies.com   
Contact: Jennifer Lytle, MD    303-482-1322      
Principal Investigator: Jennifer Lytle, MD         
United States, Florida
Clinical Neuroscience Solutions, Inc. Recruiting
Jacksonville, Florida, United States, 32256
Contact: Danielle Wilkinson    904-281-5757    dwilkinson@cnshealthcare.com   
Principal Investigator: John M Joyce, MD         
Clinical Neuroscience Solutions, Inc Recruiting
Orlando, Florida, United States, 32801
Contact: Letitia Griffin, RN    407-425-5100      
Contact: Cassandra Prescott, MHA    407-425-5100      
Principal Investigator: Linda S Harper, MD         
United States, Georgia
Institute for Advanced Medical Research Recruiting
Alpharetta, Georgia, United States, 30005
Contact: Brandon Lenfest    770-817-9200    crc4@iamresearch.org   
Principal Investigator: Angelo Sambunaris, MD         
United States, Illinois
Psychiatric Medicine Associates, LLC Recruiting
Skokie, Illinois, United States, 60076
Contact: Erick Rios    847-679-8000    Erick_Rios@rush.edu   
Contact: Ian Mackey    847-679-8000    Ian_Mackey@rush.edu   
Principal Investigator: John M Zajecka, MD         
United States, Missouri
St. Louis Clinical Trials, LC Recruiting
St. Louis, Missouri, United States, 63141
Contact: Cathy Marchlewski    314-771-6387    cmarchlewski@slct.co   
Contact: Anusha Chunduri    314-771-6387    achunduri@slct.co   
Principal Investigator: Daniel M Gruener, MD         
United States, New York
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
Contact: Adam Smith, M.D.    718-317-5522 ext 301    smith@rbany.com   
Principal Investigator: Mark Dibuono, M.D.         
United States, Ohio
Midwest Clinical Research Center, LLC Recruiting
Dayton, Ohio, United States, 45417
Contact: Otto Dueno    937-424-1050    odueno@midwestclinical.com   
Contact: Melissa Ellis    937-424-1050    mellis@midwestclinical.com   
Principal Investigator: Otto R Dueno, MD         
United States, Texas
FutureSearch Trials of Dallas Recruiting
Dallas, Texas, United States, 75231
Contact: Erin Ashmore    214-369-2600      
Contact: Stephanie Dolan    214-369-2600      
Principal Investigator: Michael Downing, MD         
Clinical Trials of Texas, Inc. Recruiting
San Antonio, Texas, United States, 78229
Contact: Dylan Marais    210-949-0122    dmarais@cttexas.com   
Contact: Lauren Coppala    210-949-0122    lcoppala@cttexas.com   
Principal Investigator: Jason C Miller, DO         
Sponsors and Collaborators
Neuralstem Inc.
Investigators
Study Director: Karl Johe, Ph.D. Neuralstem Inc.
  More Information

Publications:
Responsible Party: Neuralstem Inc.
ClinicalTrials.gov Identifier: NCT02695472     History of Changes
Other Study ID Numbers: NS2014-1 
Study First Received: February 15, 2016
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Neuralstem Inc.:
Depression
Major Depressive Disorder (MDD)
Major Depressive Disorder
Neurogenesis
Synaptogenesis
NSI-189
Neuralstem

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 21, 2016