Anti-inflammatories and Adolescent Schizophrenia

Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

Status and phase: Unknown; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Celecoxib 200mg; Drug: Minocycline 100mg; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04020588

II3/02/0618

Details and patient eligibility

About

A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Celecoxib

Active Comparator group

Description:

Celecoxib 200 mg twice a day

Treatment:

Drug: Celecoxib 200mg

Minocycline

Active Comparator group

Description:

Minocycline 100 mg twice a day

Treatment:

Drug: Minocycline 100mg

Placebo

Placebo Comparator group

Description:

Placebo capsules twice a day

Treatment:

Drug: Placebo oral capsule