Schizophrenia
Conditions
Keywords
schizophrenia, adolescents, inflammation, anti-inflammatory
Brief summary
A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia
Detailed description
Patients will be evaluated to confirm the diagnosis of schizophrenia, duration of the disease and record a history of atopic diseases or recurrent infections throughout life. The PANSS, PSP, and MCCB battery scales will be administered. A blood sample will be taken for the determination of markers of inflammation before the start of pharmacological treatment. Patients will start the antipsychotic medication assigned by their treating physician. They will also be assigned randomly to the treatment arm. The study drug will be provided by the research team under the presentation of capsules containing Celecoxib 200 mg, Minocycline 100 mg or Placebo, and patients will be instructed to take one capsule every 12 hrs daily. The patient will be reassessed with PANSS, PSP, and MCCB after completing 6 weeks of pharmacological treatment, type and dose of medication will be recorded and serum markers of inflammation will be determined again.
Interventions
DRUGCelecoxib 200mg
Will be administered for 6 weeks
DRUGPlacebo oral capsule
Will be administered for 6 weeks
Will be administered for 6 weeks
Sponsors
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia or schizophreniform disorder. * Patients in their first psychotic episode or previously diagnosed * No specific pharmacological treatment (antipsychotic at therapeutic doses in regular doses) in the previous two weeks. * Have a responsible parent or guardian.
Exclusion criteria
* Active infection * Chronic somatic diseases, including autoimmune diseases * Comorbidity with anorexia, substance use disorders * Pregnancy * Use of anti-inflammatory medications or antibiotics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity: Positive and Negative Syndrome Scale score | six weeks | Change in the Positive and Negative Syndrome Scale score, which comprises 33 items which can be scored from 1 (absent) to 7 (extreme), evaluating an array of symptoms including positive, negative, neuromotor, depressive and anxious, and involves the use of data from patient reports, caregiver reports, and clinical observations. The total score is the sum or all the items, the maximum score is 231. The higher values represent a worse outcome |
| Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores | six weeks | Change in MCCB scores. The MCCB is comprised of 9 tests that reflect 7 dimensions of neurocognitive dysfunction in schizophrenia, including: Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, and Reasoning and Problem Solving and Social Cognition. The MCCB scoring program yields the domain scores and a composite score which are standardized to the same T-score measurement scale with a mean of 50 and an SD of 10 based upon the normative data. |
Countries
Mexico
Contacts
Primary ContactRosa Ulloa, M.D
Outcome results
None listed