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

NCT ID: NCT02865629

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-09-30

Brief Summary

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

Detailed Description

To conduct an 8-week, open label study of N-acetylcysteine for the treatment of depressive symptoms in youth at high risk for bipolar disorder, with resting state functional magnetic resonance imaging (fMRI) examinations at baseline and endpoint. This proposal is innovative because it investigates the efficacy and tolerability of a novel pharmacological treatment in youth offspring of bipolar disorder, and examines the neurophysiology of predictors of mood disorders in youth at high risk for bipolar disorder. This study will obtain pilot data to propose a larger, neuroimaging-based, double-blind, placebo-controlled trial of N-acetylcysteine in youth at high risk for bipolar disorder. The expected outcome, that N-acetylcysteine will be efficacious in ameliorating depressive symptoms in youth at high risk for bipolar disorder, and that it will demonstrate improvement in functional connectivity within the left frontostriatal circuit associated with treatment response.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

N-acetyl cysteine

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

Group Type: EXPERIMENTAL

N-acetyl cysteine

Intervention Type: 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).

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).

Intervention Type: DRUG

Other Intervention Names

Acetylcysteine

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Fabiano Nery

Assistant Professor of Psychiatry in the Department of Psychiatry and Behavioral Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabiano G. Nery, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fabiano G. Nery, MD, PhD

Role: CONTACT

neryfo@email.uc.edu

513.558.5035

Facility Contacts

Stephanie Schaeper, B.S.

Role: primary

schaepsi@ucmail.uc.edu

513-558-5953

Other Identifiers

Nery UCNI NAC study

Identifier Type: -

Identifier Source: org_study_id