Does oral N-acetyl-cysteine (NAC) improve schizophrenia symptoms?
| ISRCTN | ISRCTN61794329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61794329 |
| Secondary identifying numbers | 13/08 |
- Submission date
- 08/09/2009
- Registration date
- 14/10/2009
- Last edited
- 14/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philippe Conus
Scientific
Scientific
Département de Psychiatrie
Route de Cery
Prilly
1008
Switzerland
| philippe.conus@chuv.ch |
Study information
| Study design | Randomised multicentre parallel double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.chuv.ch/psychiatrie/dpc_home/dpc_infos_organisation/dpc_cnp/dpc_cnp_schizo.html |
| Scientific title | Effects of oral N-acetyl-cysteine (NAC) in the early phase of schizophrenia spectrum psychosis: a randomised parallel double-blind placebo-controlled trial |
| Study objectives | N-acetyl-cysteine (NAC), a common antitussive drug, is able to modulate the response to oxidative stress in body tissues. The aim of the study is to evaluate the impact of oral administration of NAC in the early phase of schizophrenia, on clinical, psychopathological, neuropsychological, biochemical and neuro-physiological variables. 1. Symptomatology: does the oral administration of NAC have an impact on evolution of positive and negative symptoms, cognitive deficits? 2. Side effects of neuroleptic treatment: does the oral administration of NAC have an impact on the side effects of antipsychotic treatment? 3. Glutathione (GSH) level: does the oral administration of NAC increase the plasma and brain concentration of GSH and related compounds? 4. Mismatch negativity (MMN): does the oral administration of NAC have an impact on MMN, a pre-attentive component of electro-encephalograms found to be impaired in schizophrenic patients? |
| Ethics approval(s) | The Faculty of Biology and Medicine - Ethics Commission of Clinical Research (Faculté de Biologie et de Médecine - Commission d'éthique de la recherche clinique) approved on the 10th July 2008 (ref: 13/08) |
| Health condition(s) or problem(s) studied | Early phase psychosis |
| Intervention | Each patient gets 2700 mg NAC or placebo per day during 24 weeks. Each patient gets the NAC pills/placebo each month for four weeks. After 24 weeks we stop the NAC/placebo and there is a follow-up after 4 weeks. Then we do the last clinical interviews and take urine and blood samples. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | N-acetyl-cysteine (NAC) |
| Primary outcome measure | Improvement of the negative symptoms, measured with the Positive and Negative Syndrome Scale (PANSS - score: 1 = absence of the symptom to 7 = extreme symptoms), measured at baseline, then every month for 7 months |
| Secondary outcome measures | 1. Clinical outcome: decreased risk of relapse during the outcome period measured with the PANSS, GAF and SOFAS) 2. Neuropsychological outcome: improvement of cognition (measured with the global score of the "MATRICS" battery); and improvement of the working memory (measured with the "MATRICS" battery) 3. Functional electroencephalographic outcome: improvement of the MMN (or prevention/delay); change of the P3, response to visual stimuli 4. Magnetic resonance by spectroscopy (MRS): higher cerebral level of glutathione measured by MRS. Changes in connectivity measured by MRS and DSI, diffusion spectrum imaging. Measured at baseline (V1) and after 6 months. 5. Stratification: better response to treatment in sub-groups (high-risk/low risk GCLC genotype and/or anomalies in GSH system) |
| Overall study start date | 15/12/2008 |
| Completion date | 30/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Capability to provide informed consent 2. Male or female aged 15 to 35 years with sufficient command of French language 3. Having met threshold criteria for psychosis as defined by the "Psychosis threshold" subscale of the Comprehensive Assessment of at Risk Mental States Scale (CAARMS). This threshold is based on a combination of intensity and duration of psychotic symptoms. |
| Key exclusion criteria | 1. Severe somatic comorbidities: peptic ulcer disease, chronic inflammatory pathologies, infectious pathologies including human immunodeficiency virus (HIV), pathologies of the immune system, organic cerebral diseases, tumours, abnormal renal, hepatic, thyroid or haematological findings 2. Previous cerebral trauma 3. Substance induced psychosis or organic psychosis 4. Mental retardation (intellectual quotient [IQ] less than 70 and alteration or significant adaptation deficit). We will assess the IQ only in the case of necessity when we doubt about the intellectual skills of a patient. 5. NAC allergy 6. Treatment with antioxidants (vitamin E, selenium, multivitamins, etc.) 7. Insufficient command of French |
| Date of first enrolment | 15/12/2008 |
| Date of final enrolment | 30/11/2011 |
Locations
Countries of recruitment
- Switzerland
- United States of America
Study participating centre
Département de Psychiatrie
Prilly
1008
Switzerland
1008
Switzerland
Sponsor information
Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland)
Research organisation
Research organisation
SNSF 2009
Wildhainweg 3
PO Box 8232
Berne
CH-3001
Switzerland
| Phone | +41 (0)31 308 22 22 |
|---|---|
| kim.do@chuv.ch | |
| Website | http://www.snf.ch/E/Pages/default.aspx |
"ROR" |
https://ror.org/00yjd3n13 |
Funders
Funder type
Charity
Lausanne University Hospital, faculté de Biologie et de Médecine (CHUV) (Switzerland) - MTR Schizophrénie
No information available
Society of the French-Swiss Lottery (Loterie Romande) (Switzerland)
No information available
Swiss National Science Foundation (SNSF) (Switzerland)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Stanley Thomas Johnson Foundation (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2008 | Yes | No | |
| Results article | results | 01/09/2008 | Yes | No |
