Major Depressive DisorderNCT02724735
A Longitudinal Observational Cohort Study of NSI-189, With Out-Patients With Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Neuralstem Inc. at 12 sites in United States.
Trial summary
All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. Read more about this study
- Who is it for?
- Ages 18 to 61 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- NSI-189
- How many people
- 220 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2016to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 61 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects having completed the randomized treatment period under the NS2014-1 clinical study protocol.
Who may be able to join
- 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.
- Subject completed the 12-week randomized treatment period and final study visit for the NS2014-1 clinical study.
Who cannot join
- Subjects taking excluded medications.
- 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.
- 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.
Trial locations and contacts
12 sites in 1 country.
Karl Johe, Ph.D. contact
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Study site
Alpharetta, Georgia, 30005
- Recruiting
Study site
Dallas, Texas, 75231
- Recruiting
Study site
Dayton, Ohio, 45417
- Recruiting
Study site
Denver, Colorado, 80209
- Recruiting
Study site
Garden Grove, California, 92845
- Recruiting
Study site
Jacksonville, Florida, 32256
- Recruiting
Study site
Memphis, Tennessee, 38119
- Recruiting
Study site
National City, California, 91950
- Recruiting
Study site
Orlando, Florida, 32801
- Recruiting
Study site
San Antonio, Texas, 78229
- Recruiting
Study site
St Louis, Missouri, 63141
- Recruiting
Study site
Staten Island, New York, 10312
About this study
Official title: A Longitudinal Observational Cohort Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder
All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. The study will consist of an enrollment visit, followed by bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.
Read the detailed description
Following completion of the NS2014-1 final study visit procedures, Subjects will be offered the opportunity to enroll in this longitudinal observational cohort protocol to monitor their depression and to assess durability of effect and long-term safety of NSI-189.
The Enrollment Visit begins when informed consent is signed.The duration of the follow-up period will be up to 6 months, until the start of a new antidepressant treatment. Subjects who provide consent will be seen for in-person visits every 8 weeks, with bi-monthly phone visits occurring between in-person visits. Safety assessments and efficacy assessments will be performed at each visit. No study drug will be taken during the Longitudinal Observational Cohort study.
- Conditions
- Major Depressive Disorder
- Being tested
- NSI-189
- Keywords
- Depression, Major Depressive Disorder (MDD), Major Depressive Disorder, Neurogenesis, Synaptogenesis, NSI-189, Neuralstem
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSI-189Drug
Also called NSI-189 Phosphate
0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal Observational Cohort | Following completion of the NS2014-1 final study visit procedures, Subjects will be offered the opportunity to enroll in this longitudinal observational cohort protocol to monitor their depression and to assess durability of effect and long-term safety of NSI-189. Receives: Drug: NSI-189 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: Durability of Effect defined as the time until the start of a new antidepressant treatment (ADT)
The primary objective is to determine the durability of effect of NSI-189 phosphate compared to placebo in subjects with Major Depressive Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5TH EDITION). Durability of effect is defined as the time until the start of a new antidepressant treatment (ADT).
Measured: 6 months
Secondary outcomes (9)
Montgomery-Asberg Depression Rating Scale (MADRS)
Compare the continued Montgomery-Asberg Depression Rating Scale (MADRS) response and remission rates of subjects treated with NSI-189 to those of subjects assigned to placebo. Response is defined as a 50% or greater reduction from baseline to endpoint on the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Remission is defined as an endpoint MADRS total score of 10. The duration of 50% or greater reduction in Montgomery-Asberg Depression Rating Scale (MADRS) total score sustained following treatment will be noted.
Measured: 6 months
Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR)
Compare the continued antidepressant efficacy of NSI-189 with that of placebo.
Measured: 6 months
Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ)
Evaluate the continued efficacy of NSI-189 compared to placebo on the cognitive aspects associated with Major Depressive Disorder, and the onset and duration of improvement.
Measured: 6 months
Cogscreen Battery
Evaluate the continued efficacy of NSI-189 compared to placebo on the cognitive aspects associated with Major Depressive Disorder, and the onset and duration of improvement.
Measured: 6 months
Symptoms of Depression Questionnaire (SDQ)
Compare the continued efficacy of NSI-189 with that of placebo, as measured by the Symptoms of Depression Questionnaire (SDQ)
Measured: 6 months
Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI)
Characterize the safety and tolerability of NSI-189, compared to placebo.
Measured: 6 months
The Columbia Suicide Severity Rating Scale (C-SSRS)
Characterize the safety and tolerability of NSI-189, compared to placebo.
Measured: 6 months
17-item Hamilton Depression Rating Scale (HAMD17)
HAMD17 will be used to characterize the safety and tolerability of NSI-189, compared to placebo.
Measured: 6 months
Discontinuation rates
Characterize the safety and tolerability of NSI-189, compared to placebo.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuralstem Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Johe, Ph.D., Study director, Neuralstem Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724735
- Sponsor's protocol ID
- NS2015-2
- Status last verified
- Sep 2016
- First submitted
- 15 Mar 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Fava M, Johe K, Ereshefsky L, Gertsik LG, English BA, Bilello JA, Thurmond LM, Johnstone J, Dickerson BC, Makris N, Hoeppner BB, Flynn M, Mischoulon D, Kinrys G, Freeman MP. A Phase 1B, randomized, double blind, placebo controlled, multiple-dose escalation study of NSI-189 phosphate, a neurogenic compound, in depressed patients. Mol Psychiatry. 2016 Oct;21(10):1372-80. doi: 10.1038/mp.2015.178. Epub 2015 Dec 8.
PubMed 26643541
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Observational Cohort Study of NSI-189, a Neurogenic Compound Among Out-Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02724735
- Acronym / sponsor ID
- NS2015-2
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder (MDD), Major Depressive Disorder, Neurogenesis, Synaptogenesis, NSI-189, Neuralstem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Neuralstem Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All subjects completing the randomized treatment period in Protocol NS2014-1 will discontinue study drug and be asked to provide consent to be followed in this 6-month study, at their final safety visit. The study will consist of an enrollment visit, followed by bi-monthly in-clinic visits with monthly telephone visits between in-clinic visits.
Detailed description
Following completion of the NS2014-1 final study visit procedures, Subjects will be offered the opportunity to enroll in this longitudinal observational cohort protocol to monitor their depression and to assess durability of effect and long-term safety of NSI-189.
The Enrollment Visit begins when informed consent is signed.The duration of the follow-up period will be up to 6 months, until the start of a new antidepressant treatment. Subjects who provide consent will be seen for in-person visits every 8 weeks, with bi-monthly phone visits occurring between in-person visits. Safety assessments and efficacy assessments will be performed at each visit. No study drug will be taken during the Longitudinal Observational Cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal Observational Cohort | – | Drug: NSI-189Following completion of the NS2014-1 final study visit procedures, Subjects will be offered the opportunity to enroll in this longitudinal observational cohort protocol to monitor their depression and to assess durability of effect and long-term safety of NSI-189. |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects having completed the randomized treatment period under the NS2014-1 clinical study protocol.
Key inclusion criteria (2 listed)
- 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.
- Subject completed the 12-week randomized treatment period and final study visit for the NS2014-1 clinical study.
Key exclusion criteria (3 listed)
- Subjects taking excluded medications.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSI-189Also: NSI-189 Phosphate0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only | Drug | Longitudinal Observational Cohort |
Primary outcome
Primary Objective: Durability of Effect defined as the time until the start of a new antidepressant treatment (ADT)
Time frame: 6 months
The primary objective is to determine the durability of effect of NSI-189 phosphate compared to placebo in subjects with Major Depressive Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5TH EDITION). Durability of effect is defined as the time until the start of a new antidepressant treatment (ADT).
9 secondary outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 6 months
Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR)
Time frame: 6 months
Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ)
Time frame: 6 months
Cogscreen Battery
Time frame: 6 months
Symptoms of Depression Questionnaire (SDQ)
Time frame: 6 months
Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI)
Time frame: 6 months
The Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 6 months
17-item Hamilton Depression Rating Scale (HAMD17)
Time frame: 6 months
Discontinuation rates
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Background: PubMed 26643541Fava M, Johe K, Ereshefsky L, Gertsik LG, English BA, Bilello JA, Thurmond LM, Johnstone J, Dickerson BC, Makris N, Hoeppner BB, Flynn M, Mischoulon D, Kinrys G, Freeman MP. A Phase 1B, randomized, double blind, placebo controlled, multiple-dose escalation study of NSI-189 phosphate, a neurogenic compound, in depressed patients. Mol Psychiatry. 2016 Oct;21(10):1372-80. doi: 10.1038/mp.2015.178. Epub 2015 Dec 8.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Johe, Ph.D. contact
Karl Johe, Ph.D. study director
Neuralstem Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Neuralstem Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Johe, Ph.D. (NSI-189MDD@neuralstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective: Durability of Effect defined as the time until the start of a new antidepressant treatment (ADT) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.