Anti-inflammatories and Adolescent Schizophrenia

Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia

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

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Celecoxib 200mg; Drug: Minocycline 100mg; Drug: Placebo oral capsule

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rosa Ulloa, M.D; Phone Number: +525555739161; Email: eulloa@hotmail.com

Study Locations

• Mexico
  • Ni Ee.uu. Ni Canadá
    • Mexico City, Ni Ee.uu. Ni Canadá, Mexico, 14080
      • Recruiting
      • Hospital Psiquiatrico Infantil
      • Contact: Rosa E Ulloa, M.D.; Phone Number: 5555739161; Email: eulloa@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsules twice a day	Drug: Placebo oral capsule; Will be administered for 6 weeks; Other Names: Placebo
Active Comparator: Celecoxib; Celecoxib 200 mg twice a day	Drug: Celecoxib 200mg; Will be administered for 6 weeks; Other Names: Minocycline; Minocycline 100 mg
Active Comparator: Minocycline; Minocycline 100 mg twice a day	Drug: Minocycline 100mg; Will be administered for 6 weeks; Other Names: Minocycline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom severity: Positive and Negative Syndrome Scale score	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	six weeks
Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores	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.	six weeks

Collaborators and Investigators

• Sponsor: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: schizophrenia; adolescents; anti-inflammatory; inflammation
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anti-Bacterial Agents; Cyclooxygenase 2 Inhibitors; Celecoxib; Minocycline
• Other Study ID Numbers: II3/02/0618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No