NCT03509597: CORTEX-SP

Brain Image Markers Associated With Cognitive Training and Aerobic Exercise in Schizophrenia

Status unknown NA Last updated 30 July 2019

What this trial tests

NA trial testing Aerobic Exercise in Schizophrenia in 150 participants. Status unknown.

Timeline

1 March 2017

Primary endpoint
31 December 2019

1 June 2020

Quick facts

Lead sponsor	Red Salud Mental Araba
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	150
Start date	1 March 2017
Primary completion	31 December 2019
Estimated completion	1 June 2020
Sites	1 location across Spain

Drugs / interventions tested

• Aerobic Exercise — full drug profile →
• Cognitive Training
• Treatment as usual
• Occupational Activities

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

Red Salud Mental Araba

Who can join

Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the brain correlates of Cognitive Training and Aerobic Exercise in schizophrenia. A third of participants will receive Cognitive Training plus Standard Care for schizophrenia. Another third of participants will receive Aerobic Exercise Training plus Standard Care for schizophrenia. A control group will of participants will receive Standard Care plus Occupational Activities for the same duration and frequency as the experimental groups.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cognitive, creative, functional, and clinical symptom improvements in schizophrenia after an integrative cognitive remediation program: a randomized controlled trial.
   Sampedro A, Peña J, Sánchez P, Ibarretxe-Bilbao N, et al · · 2021 · cited 12× · PMID 34711835 · DOI 10.1038/s41537-021-00181-0
2. Mediating role of cognition and social cognition on creativity among patients with schizophrenia and healthy controls: Revisiting the Shared Vulnerability Model.
   Sampedro A, Peña J, Ibarretxe-Bilbao N, Sánchez P, et al · · 2020 · cited 9× · PMID 31707749 · DOI 10.1111/pcn.12954
3. Clinical, physical, physiological, and cardiovascular risk patterns of adults with schizophrenia: CORTEX-SP study: Characterization of adults with schizophrenia.
   Tous-Espelosin M, de Azua SR, Iriarte-Yoller N, MartínezAguirre-Betolaza A, et al · · 2021 · cited 6× · PMID 33246589 · DOI 10.1016/j.psychres.2020.113580
4. Brain White Matter Correlates of Creativity in Schizophrenia: A Diffusion Tensor Imaging Study.
   Sampedro A, Peña J, Ibarretxe-Bilbao N, Cabrera-Zubizarreta A, et al · · 2020 · cited 3× · PMID 32655352 · DOI 10.3389/fnins.2020.00572
5. The impact of creativity on functional outcome in schizophrenia: a mediational model.
   Sampedro A, Peña J, Sánchez P, Ibarretxe-Bilbao N, et al · · 2021 · cited 2× · PMID 33637749 · DOI 10.1038/s41537-021-00144-5
6. Differential Responsiveness to Exercise and Cognitive Remediation in Physical Health in People With Schizophrenia: Results From the CORTEX-SP Study.
   Tous-Espelosin M, Iriarte-Yoller N, Sampedro A, Lasa-Sagaseta I, et al · · 2026 · PMID 42141376 · DOI 10.1002/ejsc.70182
7. Theory-of-mind improvement in schizophrenia after integrative cognitive remediation: which patients benefit more?
   Sampedro A, Peña J, Sánchez P, Ibarretxe-Bilbao N, et al · · 2025 · PMID 40735250 · DOI 10.1016/j.scog.2025.100380
8. As We Were and As We Should Be, Combined Exercise Training in Adults With Schizophrenia: CORTEX-SP Study Part II.
   Tous-Espelosin M, Pavon C, Elizagarate E, Sampedro A, et al · · 2024 · PMID 39054763 · DOI 10.1111/sms.14707