Bipolar depression MedDRA version: 19.0 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Mucolysin, mucomyst, Granon
Product Name: NAC
Product Code: R05CB01
Pharmaceutical Form: Capsule
INN or Proposed INN: N-acetylcystin
CAS Number: 7218-04-4
Other descriptive name: S-1,2-DIC
Sponsors
Mental Health Service, Esbjerg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients that meet the DSM-5 criteria of bipolar disorder type 1 or 2 (296-41-296.56 or 296.89) with at least one documented illness episode in the past six months, have had depressive symptoms at least 4 weeks before inclusion, MADRS = 18 at baseline, have been sick at least 4 weeks, between 18-64 years, fertile women with a negative pregnant test at baseline, turtle women using safe contraception in the study period, and patients who have given informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant women, patients wishing pregnancy during the frame of the study, current suicidal thoughts, patients that have an intake of more than 500 mg NAC, 200 µm selenium, eller 500 IU of vitamin E every day is excluded. Patients who are hypersensitive to histamin, snf patients who have had ECT-treatment within the last 4 weeks, or have had medication change within the last 4 weeks. Patients with recent bleeding in respiratory, asthma, epilepsi or allergy towards NAC. People who cannot speak or understand the Danish language, or have not give or withdrawn informed consent. If patients change diagnosis during the study, and the primary diagnosis is not bipolar affective disorder is the participant excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to identify the effect of NAC on the depressive symptoms in patients with bipolar depression;Secondary Objective: The secondary outcom is to measure the level of oxidative stress, quality of life and level of function.;Primary end point(s): The total score of MADRS;Timepoint(s) of evaluation of this end point: Baseline, 2, 10, 20 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Score of MES, SF-12, GAF-S, GAF-F, CGI-S, YMRS and measurement of oxidativ stress in biological material (urine);Timepoint(s) of evaluation of this end point: Baseline, 2, 10, 20 and 24 weeks | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Information
Mental Health Service, Esbjerg
Outcome results
None listed