Anti-inflammatories and Adolescent Schizophrenia

Phase 4

• Conditions: Schizophrenia
• Interventions: Drug: Placebo oral capsule; Drug: Minocycline 100mg; Drug: Celecoxib 200mg

• Registration Number: NCT04020588
• Lead Sponsor: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

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.

Study Timeline

• Study Start: 2019-02-25
• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral capsule	Placebo capsules twice a day
Minocycline	Minocycline 100mg	Minocycline 100 mg twice a day
Celecoxib	Celecoxib 200mg	Celecoxib 200 mg twice a day

Primary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

Hospital Psiquiatrico Infantil; 🇲🇽 Mexico City, Ni Ee.uu. Ni Canadá, Mexico