Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02972398 : N-Acetyl Cysteine Supplementation in Therapy Refractory Major Depressive Disorders
PhaseN/A
AgesMin: 18 Years Max: 65 Years
Eligibility
Inclusion Criteria:

- a current episode of MDD diagnosed according to Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition (DSM-IV-TR) diagnosed with SCID

- an age between 18 and 65 years

- a total score of HAMD-17 ? 17

- a CRP level between 0.85 and 10 mg/L (The CRP range is based on literature values for
mild to moderate chronic inflammation, while values > 10 mg/L point at acute
inflammation. A pilot study at the Tianjin Hospital (n=62) indicated that
approximately one third of all patients with MDD will have CRP values within this
range). insufficient response to 1 or more antidepressants given for at least 6 weeks
and in an adequate dose during the current episode

- stable dose of the current antidepressant drug for at least 2 weeks prior to
initiation of the study

- Patients are allowed to use benzodiazepines (BZD) to relieve anxiety during the first
phase of antidepressant treatment (Anding Hospital protocol). Benzodiazepines may
also be prescribed because of sleeping problems during the trial. BZD use will be
recorded at all assessments during the trial and after follow-up.

- Patients are compliant with treatment according to the judgement of the treating
clinician.

- Female subjects will be eligible to participate in the study if they are of
non-childbearing potential or of child-bearing potential and willing to practice
appropriate birth control methods during the study. Clinical patients always get a
pregnancy test before start of treatment.

- Participant or guardian has to sign informed consent. The patients' guardians will
sign the informed consent on behalf of the participants when the capacity of
participants to consent is compromised.

Exclusion Criteria:

- A history of manic episode

- Use of mood stabilizer

- Use of antipsychotic medication with more than half of the maximum dosage suggested
in the instruction

- History of substance abuse or dependence

- An allergic reaction to NAC or any component of the preparation

- Severe somatic diseases that might interfere with regular antidepressant treatment
including conditions such as kidney and liver failure, uncontrolled hypertension,
cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes,
epilepsy and asthma.

- Use of anti-inflammatory medication for longer than 7 days in the last two months
preceding the trial

- Use of immunosuppressive medication such as oral steroid hormones

- History of chronic infection, such as Tuberculosis, AIDS, hepatitis

- CRP value > 10 mg/L

- Women in pregnancy or lactation period
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02972398      |      Link to official Clinicaltrials.gov listing
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