Self-HarmPhase 2NCT04005053
Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents
A Phase 2 study testing N-acetyl cysteine in people with Self-Harm and Depression, run by University of Minnesota at 1 site in United States.
Trial summary
To measure NAC-induced changes to concentrations of glutathione (GSH) in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) in 36 adolescents and young adults with NSSI (12 in each group: high, low, and placebo). Read more about this study
- Who is it for?
- Ages 16 to 24 years, women only
- Conditions the study is for
- Self-Harm, Depression, Suicide
- What is being tested?
- N-acetyl cysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Current frequency of at least one NSSI episode in the past 2 months
- ≥ 5 past episodes of NSSI with significant tissue damage (e.g. scars present)
- Psychotropic medications are dose-stable for 1 month
- Ability to understand study procedures and to comply with them for the entire length of the study
Who cannot join
- Any MRI contraindications (e.g. metal plates, claustrophobia, braces, implanted devices)
- Any current serious medical illness as defined by medical history
- Current Substance Use Disorder (except Tobacco Use Disorder)
- Primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder)
- Neurodevelopmental disorder such as mental retardation or autism
- Changes in psychotropic medications in past 1 month
Show all 10Show fewer
- Taken NAC or glutathione on a regular basis in the past 6 months
- Currently pregnant, planning to become pregnant, currently breastfeeding, or unwillingness to use contraception throughout the study.
- Allergy/sensitivity to N-acetylcysteine.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Identifying Biological Signatures of N-Acetylcysteine for Non-Suicidal Self-Injury in Adolescents and Young Adults
To measure NAC-induced changes to concentrations of glutathione (GSH) in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) in 36 adolescents and young adults with NSSI (12 in each group: high, low, and placebo).
Read the detailed description
This study is a double-blind, placebo controlled, 4-week course of two-tiered N-acetylcysteine (NAC) dosing focused on identifying the optimal dose to achieve meaningful change in measurable biomarkers (glutathione and glutamate).
This design will allow us to confirm acute biological changes, select the optimal dose for achieving biological effects, and examine dose/concentration-response relationships with respect to biological markers and pharmacokinetics.
Brief schedule of activities: Subjects will be recruited through community and clinical settings and screened over the phone. There will be a total of 4 in-person visits and two sets of on-line study activities.
Eligible participants will be assigned to one of 3 groups (double-blinded): a low-dose NAC group (3600 mg/day), a high-dose NAC group (5400mg/day), and placebo (PBO). The study intervention period is 4 weeks. Total participation is up to 8 weeks, depending on the length of time between Day 0 and Day 1.
The investigators will recruit 36 adolescents and young adults aged 16-24 years. There will be 12 participants in each group (PBO, 3600mg/day, 5400mg/day). The investigators will use a minimization procedure to ensure that the participants in these 3 groups will have similar age, clinical severity and medication status.
- Conditions
- Self-Harm, Depression, Suicide
- Being tested
- N-acetyl cysteine, Placebo oral tablet
- Medical subject headings
- Self-Injurious Behavior, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called N-acetylcysteine
3600 or 5400 mg/day N-acetyl cysteine
Placebo oral tabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose NAC | Experimental | 3600 NAC mg/day Receives: Drug: N-acetyl cysteine |
| High-Dose NAC | Experimental | 5400 NAC mg/day Receives: Drug: N-acetyl cysteine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Increase in Glutathione (GSH) Concentrations in the ACC
increase in glutathione (GSH) concentrations in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS)
Measured: 28 days
Secondary outcomes (2)
Change in GSH Reduced-to-oxidized Ratio
Percent increase in reduced-to-oxidized ratio of glutathione (GSH) in the blood compared to baseline
Measured: 28 days
Change in Glutamate Concentrations
Percent decrease in the concentrations of glutamate (GLU) in the anterior cingulate cortex (ACC) measured by MRS
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Aug 2019
- Primary completion8 May 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-HarmStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005053
- Sponsor's protocol ID
- PSYCH-2018-26890
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2019
- Last updated
- 15 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sahasrabudhe SA, Silamongkol T, Park YW, Colette A, Eberly LE, Klimes-Dougan B, Coles LD, Cloyd JC, Oz G, Mueller BA, Kartha RV, Cullen KR. Identifying Biological Signatures of N-Acetylcysteine for Non-Suicidal Self-Injury in Adolescents and Young Adults. J Psychiatr Brain Sci. 2021;6:e210007. doi: 10.20900/jpbs.20210007. Epub 2021 Apr 29.
PubMed 34036177
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Biological Signatures of N-Acetylcysteine for Non-Suicidal Self-Injury in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT04005053
- Acronym / sponsor ID
- PSYCH-2018-26890
- Conditions
- Self-Harm, Depression, Suicide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 8 May 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Posted 15 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To measure NAC-induced changes to concentrations of glutathione (GSH) in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) in 36 adolescents and young adults with NSSI (12 in each group: high, low, and placebo).
Detailed description
This study is a double-blind, placebo controlled, 4-week course of two-tiered N-acetylcysteine (NAC) dosing focused on identifying the optimal dose to achieve meaningful change in measurable biomarkers (glutathione and glutamate).
This design will allow us to confirm acute biological changes, select the optimal dose for achieving biological effects, and examine dose/concentration-response relationships with respect to biological markers and pharmacokinetics.
Brief schedule of activities: Subjects will be recruited through community and clinical settings and screened over the phone. There will be a total of 4 in-person visits and two sets of on-line study activities.
Eligible participants will be assigned to one of 3 groups (double-blinded): a low-dose NAC group (3600 mg/day), a high-dose NAC group (5400mg/day), and placebo (PBO). The study intervention period is 4 weeks. Total participation is up to 8 weeks, depending on the length of time between Day 0 and Day 1.
The investigators will recruit 36 adolescents and young adults aged 16-24 years. There will be 12 participants in each group (PBO, 3600mg/day, 5400mg/day). The investigators will use a minimization procedure to ensure that the participants in these 3 groups will have similar age, clinical severity and medication status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose NAC | Experimental | Drug: N-acetyl cysteine3600 NAC mg/day |
| High-Dose NAC | Experimental | Drug: N-acetyl cysteine5400 NAC mg/day |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Current frequency of at least one NSSI episode in the past 2 months
- ≥ 5 past episodes of NSSI with significant tissue damage (e.g. scars present)
- Psychotropic medications are dose-stable for 1 month
- Ability to understand study procedures and to comply with them for the entire length of the study
Key exclusion criteria (10 listed)
- Any MRI contraindications (e.g. metal plates, claustrophobia, braces, implanted devices)
- Any current serious medical illness as defined by medical history
- Current Substance Use Disorder (except Tobacco Use Disorder)
- Primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder)
- Neurodevelopmental disorder such as mental retardation or autism
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 |
|---|---|---|
| N-acetyl cysteineAlso: N-acetylcysteine3600 or 5400 mg/day N-acetyl cysteine | Drug | High-Dose NAC, Low-Dose NAC |
| Placebo oral tabletPlacebo | Drug | Placebo |
Primary outcome
Percent Increase in Glutathione (GSH) Concentrations in the ACC
Time frame: 28 days
increase in glutathione (GSH) concentrations in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS)
2 secondary outcomes
Change in GSH Reduced-to-oxidized Ratio
Time frame: 28 days
Change in Glutamate Concentrations
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34036177Sahasrabudhe SA, Silamongkol T, Park YW, Colette A, Eberly LE, Klimes-Dougan B, Coles LD, Cloyd JC, Oz G, Mueller BA, Kartha RV, Cullen KR. Identifying Biological Signatures of N-Acetylcysteine for Non-Suicidal Self-Injury in Adolescents and Young Adults. J Psychiatr Brain Sci. 2021;6:e210007. doi: 10.20900/jpbs.20210007. Epub 2021 Apr 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetyl cysteine in people with Self-Harm and Depression, run by University of Minnesota at 1 site 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Increase in Glutathione (GSH) Concentrations in the ACC (time frame: 28 days). 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 NCT04005053, 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 15 Aug 2023.