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Trial record 2 of 8 for:    Neuralstem

Study of NSI-189 for Major Depressive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02695472
First Posted: March 1, 2016
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neuralstem Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Symptoms of Depression Questionnaire (SDQ) [ Time Frame: Up to 12 weeks ]
  • The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ) [ Time Frame: Up to 12 weeks ]
  • 17-item Hamilton Rating Scale for Depression (HAMD17) [ Time Frame: Up to 12 weeks ]
  • Clinical Global Impressions - Severity and Improvement (CGI-S, CGI-I) [ Time Frame: Up to 12 weeks ]
  • Cogstate Brief Battery [ Time Frame: Up to 12 weeks ]
    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 ]
    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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695472


Locations
United States, California
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
Synergy San Diego
National City, California, United States, 91950
United States, Colorado
Clinical Trials of the Rockies
Denver, Colorado, United States, 80209
United States, Florida
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States, 32801
United States, Georgia
Institute for Advanced Medical Research
Alpharetta, Georgia, United States, 30005
United States, Illinois
Psychiatric Medicine Associates, LLC
Skokie, Illinois, United States, 60076
United States, Missouri
St. Louis Clinical Trials, LC
St. Louis, Missouri, United States, 63141
United States, New York
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, Ohio
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States, 45417
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75231
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
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
First Submitted: February 15, 2016
First Posted: March 1, 2016
Last Update Posted: February 24, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
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