N-acetylcysteine in the Treatment of Depressive Symptoms in Bipolar Offspring

NCT02865629 | Unknown DMC

• 1 other identifier: Nery UCNI NAC study
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HAM-D) scores

  The primary outcome will be change in depressive symptoms, as measured by HAMD scores, from baseline to endpoint.

  Baseline to endpoint (8 weeks)

Secondary Outcomes (5)

• Young Mania Rating Scale (YMRS) scores

  Baseline to endpoint (8 weeks)

• Hamilton Anxiety Rating Scale (HAM-A) scores to measure anxiety symptoms

  Baseline to endpoint (8 weeks)

• Clinical Global Impression of Severity (CGI-S) scores

  Baseline to endpoint (8 weeks)

• Connectivity index, as defined by the temporal bivariate correlation between fMRI signal fluctuations in the left ventrolateral prefrontal cortex and the left striatum

  Baseline to endpoint (8 weeks)

• Correlation between change in depressive symptoms and change in connectivity index

  Baseline to endpoint (8 weeks)

Study Arms (1)

N-acetyl cysteine

EXPERIMENTAL

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

Drug: N-acetyl cysteine

Interventions

N-acetyl cysteine DRUG

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).

Also known as: Acetylcysteine

N-acetyl cysteine

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female subjects 15 years, 0 months - 24 years, 11 months of age at screening
• For minor, at least one parent or step-parent/guardian with whom the subject lives is willing to participate in research sessions
• For minor, the child and relative(s) are able and willing to give written informed assent/consent to participate, respectively
• 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)
• Subject shows evidence of current significant depressive symptoms as determined by a current Hamilton Depression Rating Scale (HAM-D) greater or equal to 8

You may not qualify if:

• 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
• Patient has a DSM-5 diagnosis of autism, pervasive developmental disorder, OCD, PTSD, or Tourette's disorder
• 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
• 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
• Patient has history of major neurological disorders (such as epilepsy), or head trauma with \> 10 minutes loss of consciousness
• Patient has evidence of mental retardation (IQ less than 70), as determined by the Wechsler Abbreviated Scale of Intelligence (WASI)
• 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
• Patient has history of allergic reaction to N-acetylcysteine

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Fabiano G. Nery, MD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiano G. Nery, MD, PhD

CONTACT

513.558.5035; neryfo@email.uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry in the Department of Psychiatry and Behavioral Neuroscience

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: August 12, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)