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Investigating the Effect of Adding N-acetylcysteine to Treatment in Bipolar Depression

Investigating the effect of adding N-acetylcysteine to treatment compared to placebo on improving depressive symptoms in patients with bipolar disorder: a clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251011067589N1
Enrollment
50
Registered
2025-11-09
Start date
2025-12-22
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in Bipolar patients. Bipolar disorder, current episode depressed, severe, without psychotic features

Interventions

Intervention 1: Intervention Group: Patients in the intervention group will receive, in addition to the standard pharmacological treatment they have been already receiving, a daily dose of 1800 mg to

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with bipolar depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. A score greater than 8 on the Hamilton Depression Rating Scale. Patients hospitalized in the Psychiatry Ward of Golestan Hospital Patients in the age range of 18-65 years

Exclusion criteria

Exclusion criteria: The use of any other medication that has antidepressant effects, except for the study drug, or mood stabilizers or antipsychotics that have been initiated for the patient. The presence of comorbid psychiatric disorders such as schizoaffective disorder or other psychotic disorders like schizophrenia Acute substance, sedative, or alcohol dependence or abuse within the past 12 months (excluding nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for substance dependence, or a positive urine drug test at the start of the study Sensitivity to N-acetylcysteine or to any of the components present in the placebo. Diagnosis of major depressive disorder (unipolar depression) based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Diagnosis of a manic episode based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Individuals with intellectual disabilities or other cognitive disorders Neurological disorders such as dementia, delirium, head trauma, or seizure disorders Pregnant women

Design outcomes

Primary

MeasureTime frame
Depressive symptoms. Timepoint: At the beginning of study and 4th and 8th week of study. Method of measurement: Hamilton Depression Rating Scale.

Secondary

MeasureTime frame
Cognitive function. Timepoint: At the beginning of study and 4th and 8th week of study. Method of measurement: Montreal Cognitive Assessment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Norouzi

Ahvaz University of Medical Sciences

norouzi-s@ajums.ac.ir+98 61 3320 4501

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026