Health Condition 1: null- Obsessive-Compulsive Disorder
Conditions
Interventions
Intervention1: N-Acetylcysteine: The patients in N-acetylcysteine group will be given a trial of N-acetylcysteine starting from 600mg which would be increased weekly by 600mg to 2400mg in 3 weeks, at
Sponsors
Postgraduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Primary diagnosis of Obsessive-compulsive disorder (OCD) as per International Classification of Diseases 10 (ICD-10)or Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV TR) 2. Diagnosis made by a competent psychiatrist (having an MD degree i.e. Consultants or Senior Residents) at Postgraduate Institute of Medical Education and Research(PGIMER), Chandigarh 3. As a significant proportion of patients with OCD lack insight, distress or resistance and their level frequently fluctuates with age and treatment so these patients will be included in the study 4. Age group: 7 years to 5. Juvenile onset Obsessive-compulsive disorder (Onset of Obsessive-Compulsive symptoms before 18 years of age) 6. Inadequate response (CY-BOCS score 12 or more) 7. On treatment with Serotonin Reuptake Inhibitors or Behaviour Therapy or both (in combination or sequential treatment in any sequence) 8. Stable medical regimen of Serotonin Reuptake Inhibitors (1 or more) or Behaviour Therapy or combination of both for OCD for 12 weeks or more 6. Patients on Cognitive Behavioural Therapy (CBT) for co-morbid depression or anxiety for any length of time will be included
Exclusion criteria
Exclusion criteria: 1. Any Co-morbid psychiatric diagnosis (including neuro-developmental disorders) as seen in records or on baseline assessment except Mild-Moderate Depression, Anxiety symptoms not meeting criteria for any Specific Anxiety disorder or Obsessive-Compulsive related disorders (e.g. Trichotillomania, Skin excoriation disorder, Hording disorder, Body dysmorphic disorder) 2. Significant medical or surgical conditions, known or suspected based on records or clinical history and examination 3. Patients enrolled in other interventional study pharmacological or psychotherapeutic (for medical or psychiatric disorder) 4. Males aged 13 years or more, testing positive on urine drug screen 5. Females aged 13 years or more, testing positive on urine pregnancy screen 6. Pregnant or Lactating Females or Females intending to get pregnant or refusing to use contraception during study 7. Patients who have taken or are on N-acetyl Cysteine (alone or in combination) in past for OCD 8. Patients with H/O Asthma or Hypersensitivity to N-acetyl Cysteine alone or in combination 9. The patients or caregivers not consenting for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare improvement in Obsessive-Compulsive symptoms with N-Acetylcysteine augmentation treatment group compared with control groupTimepoint: Baseline, then at weekly intervals till N-acetyl Cysteine is increased to 2400mg, thereafter at 4weekly intervals and at the end of trial End of trial would be after 15 weeks of actual beginning of trial in a patient or till patient leaves the trial whichever earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare improvement in depressive symptoms with N-Acetylcysteine augmentation treatment compared with control group 2. To compare improvement in CGI scale, Functioning with N-Acetylcysteine augmentation treatment compared with control group 3. To study side-effects of N-acetyl Cysteine in juvenile OCD patientsTimepoint: Baseline, then at weekly intervals till N-acetyl Cysteine is increased to 2400mg, thereafter at 4weekly intervals and at the end of trial End of trial would be after 15 weeks of actual beginning of trial in a patient or till patient leaves the trial whichever earlier In case of adverse-effects assessment will be as soon as possible especially medical evaluation of adverse-effects | — |
Countries
India
Contacts
Public ContactDr Susanta Kumar Padhy
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed