Effects of add-on Celecoxib treatment in patients with schizophrenia spectrum disorders and inflammatory cytokine profile (TargetFlame)
- Conditions
- Schizophrenie oder schizophrene Spektrum-erkrankungF20Schizophrenia
- Registration Number
- DRKS00029044
- Lead Sponsor
- Bezirkskliniken Schwaben
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 109
• A DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder
• PANSS total = 55 at screening
• An inflamed peripheral profile (see definition below)
• Exclusion of a yet non-detected rheumatological or HBV/HCV disease following the screening defined in this protocol
• Any antipsychotic treatment being stable for one week prior to inclusion
• Inpatients and outpatients
• Age between 18 and 65 years
• Written informed consent obtained from the participant prior to performing any protocolrelated procedures, including screening evaluations
• Female participants with reproductive potential must have a negative pregnancy test using a pregnancy test strip as part of the screening visit
• Female participants with an inflamed profile and reproductive potential must have a negative serum pregnancy test within seven days prior to randomization
• Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening.
This includes:
• A woman who is not capable of bearing a child is defined as follows: post-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum-FSH-values (folliclestimulating hormone) of >40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation.
• A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures.
• Medically-approved acceptable methods of contraception with a low failure rate (i.e. less than 1% per year) when used consistently and correct can include the following: hormonal contraceptives, intrauterine device and double barrier method. Acceptable preventive measures can include total abstinence at the discretion of the investigator, in cases where compliance is ensured because of the study participant's age, occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar,
ovulation, symptothermal methods or abstinence until the 4th day after the ovulation) as well as coitus interruptus are not acceptable methods of contraception.
• A reliable method of contraception (CTFG guideline) must be used for the entire duration of the study.
• Patients who are unable to give informed consent;
• Coercive treatment or forced placement in a psychiatric hospital at the time of study inclusion;
• Patients who have acute suicidal ideations according to the clinical standard assessment;
• Medical history of an immune-mediated brain disorder;
• Chronic use of glucocorticosteroids (temporary use is permitted, if stopped at least 1 month before start of treatment trial);
• Chronic use of non-steroidal anti-inflammatory drugs (temporary use is permitted, if stopped at least 1 month before start of treatment trial; on-demand use is permitted only as topic application);
• Current use of statins or other lipid-lowering drugs;
• Current use of tacrolimus or fluconazole;
• Current use of antihypertensives from the substance class of ACE inhibitors or AT-II antagonists or beta-blockers with the exception of propranolol;
• Current use of diuretics;
• Current use of carbamazepine;
• Chronic use of antiplatelet agents (e.g ASS, clopidogrel), marcumar or Non-vitamin K Antagonist Oral anticoagulants (NOAK);
• Known history of treatment-resistant hypertension;
• Known history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
• Known history of congestive heart failure (NYHA II-IV) or current use of digoxin;
• Known history of type 2 diabetes mellitus;
• Severe liver disorder(s) (serum albumin <25 g/l or Child-Pugh score >10);
• Severe kidney disorder(s) (estimated creatinine clearance <30 ml/min);
• Known history of systemic dermatological disorders;
• Known history of ulcer disease or gastrointestinal (GI) bleeding;
• Known history of inflammatory bowel disease;
• Pregnancy or breast-feeding;
• For male participants: Pregnancy or breast-feeding of the partner
• Intolerance to one of the study drugs;
• Known hypersensitivity to sulphonamides;
• Known history of asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergictype reactions after taking acetylsalicylic acid(aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs) including COX-2 (cyclooxygenase-2)
inhibitors;
• Known history of hereditary Galactose-intolerance, complete Lactase-deficiency or Glucose-Galactose-malabsorption disorder;
• Concurrent enrolment in another clinical trial where the participant is receiving an IMP or participation in another clinical trial with IMP during the last 30 days before inclusion or 7 half-lives of previously used IMP, whichever is longer.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to investigate improvements in psychopathology in patients with schizophrenia spectrum disorders having an inflammatory blood profile randomized to either Celecoxib or placebo.<br>Reduction in symptom severity in randomized patients following treatment with add-on Celecoxib compared to control patients following treatment with add-on placebo as assessed by total PANSS score changes from baseline to two months (56 days) after treatment initiation.
- Secondary Outcome Measures
Name Time Method Secondary and exploratory objectives include differences in side effects, symptom severity, safety measures and cognitive functions as detailed below.<br>• Disease severity in the positive, negative and general psychopathology dimensions assessed using the P-PANSS, N-PANSS and GP-PANSS subscale scores after 2 and 6 months compared to baseline<br>• Andreasen Remission criteria after 2 and 6 months compared to baseline<br>• Global Assessment of Functioning scale (GAF) score after 2 and 6 months compared to baseline