Recruiting

N-Acetylcysteine

Sponsor:

University of Cincinnati

Code:

NCT02865629

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Interventions

N-acetyl cysteine

Study Details

Brief summary:

N-acetylcysteine in the treatment of depressive symptoms in youth at high-risk for bipolar disorder: a functional connectivity study

Conditions

Depression

Study ID

NCT02865629

Start date

Aug, 2016

Status verified date

May, 2018

Completion date

Sep, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Inclusion:

1. Male or female subjects 15 years, 0 months - 24 years, 11 months of age at screening
2. For minor, at least one parent or step-parent/guardian with whom the subject lives is willing to participate in research sessions
3. For minor, the child and relative(s) are able and willing to give written informed assent/consent to participate, respectively
4. Subject has at least one first degree relative with Bipolar I Disorder, as assessed by the Structured Clinical Interview for DSM (SCID) or the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL)
5. Subject shows evidence of current significant depressive symptoms as determined by a current Hamilton Depression Rating Scale (HAM-D) greater or equal to 8

Exclusion:

1. Patient has presence of current or lifetime history of manic or hypomanic mood episodes, psychotic disorders including schizophrenia, current major depressive episode, and/or more than two prior major depressive episodes
2. Patient has a DSM-5 diagnosis of autism, pervasive developmental disorder, OCD, PTSD, or Tourette's disorder
3. Patient has drug or alcohol abuse or dependence disorders in the three months prior to study recruitment, although a lifetime history of substance or alcohol disorders can be present if the patient has been abstinent for at least three months
4. Pregnancy; participants will be encouraged but not mandated to discuss a positive pregnancy test with their guardians (if minors) and we will follow local laws
5. Patient has history of major neurological disorders (such as epilepsy), or head trauma with > 10 minutes loss of consciousness
6. Patient has evidence of mental retardation (IQ less than 70), as determined by the Wechsler Abbreviated Scale of Intelligence (WASI)
7. Patient has any contraindication for MRI, including metal in the body related to an injury or surgery (e.g., surgical clips, metal fragments in the eyes), piercings that cannot be removed, or braces
8. Patient has history of allergic reaction to N-acetylcysteine

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: N-acetyl cysteine

Following the screening and review of all laboratory studies, patients will be scheduled to receive N-acetylcysteine.

Interventions

N-acetyl cysteine

N-acetylcysteine will be initiated at 600 mg PO daily for Week 1, then increased to 600 mg PO twice a day for Week 2, then increased to 600 mg PO morning and 1200 mg PO evening for Week 3, and then increased to 1200 mg PO twice a day for Week 4-8. Doses might be decreased anytime if clinically indicated. Following the study, all patients will be referred to treatment as usual. Adherence will be assessed in weekly visits in the first month and then bi-weekly in the second month. Adherence will be assessed by subject interview, pill counts during each study visit, and by legal guardian interview (if minor).

Primary outcome measure

  • Hamilton Depression Rating Scale (HAM-D) scores [ Time Frame: Baseline to endpoint (8 weeks) ]

Central Contacts and Locations

Central contacts

Fabiano G. Nery, MD, PhD

513.558.5035neryfo@email.uc.edu

Locations

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Stephanie Schaeper, B.S.

513-558-5953schaepsi@ucmail.uc.edu

Principal Investigator:

Fabiano Nery, MD

More Information

Sponsor

University of Cincinnati

Last update posted

May 14, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2018-05-14.