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Completed

NCT Number: NCT02341131

Cognitive Remediation Therapy in Schizophrenia: Effects on BDNF Levels

The main objective of the study is to analyse the role of a neurotrophic factor (BDNF) as a putative biological marker of the cognitive recovery in schizophrenia following a Cognitive Remediation Therapy (CRT). Additionally, the role as outcome predictors of BDNF serum levels and the Val66met polymorphism and data from functional and structural neuroimaging will be studied.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic Barcelona

Barcelona, 08036, Spain

About this study

Forty patients with schizophrenia disorder and twenty healthy volunteers will be recruited. Patients will be randomly allocated either the experimental group, undergoing an individual CRT for 40 hours during 16 weeks, or the control group following a psycho-educational intervention without any neurocognitive work, both lasting the same amount of hours and period of time. Blood samples will be obtained from participants in four moments: before treatment, at week 4, at week 16, and at 32 week follow-up. In addition, repeated measurements will be obtained with a neurocognitive battery based on the MATRICS consensus battery and the Positive And Negative Syndromes Scale (PANSS). Assessments will be conducted by trained personnel who will remain blind to the group assignment. A factorial model will be performed conducting a repeated measures analysis of covariance (ANCOVA) to study the effects of CRT on the levels of BDNF, neurocognition, symptoms and social functioning, adding the necessary co-variants. Finally, a linear regression model to determine the predictive role of serum levels of BDNF and data from functional and structural neuroimaging on the effects of CRT will be performed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of schizophrenia according to DSM-IV-TR and confirmed by the semi-structured interview (SCID) for the axis 1.
  • Presence of cognitive deficit confirmed by the neuropsychological battery
  • Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment.

Exclusion criteria

  • Presence of organic-cerebral affectation due to neurological or traumatic conditions
  • Abuse of psychotropic substances
  • Presence of other psychiatric symptomatology

Treatment and study plan

Cognitive Remediation Therapy

Behavioral

The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.

Other names: Cognitive rehabilitation, cognitive training

Psychoeducation

Behavioral

The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes teaching information and coping skills and neuropsychological issues are not addressed.

Other names: Coping strategies, skills training

Primary outcomes

  1. BDNF (change from baseline serum BDNF levels)

    Time frame: Baseline, 1 month and 4 months

    Change Measurements of serum BDNF levels will be carried out by personnel blind to subjects' group assignment. Platelet and serum samples will be diluted with diluent included in the R&D Human BDNF Quantikine Enzym Linked Immunosorbent Assay (ELISA) kit (Yasuhito et al. 1987).

Secondary outcomes

  1. Symptoms (Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores)

    Time frame: Baseline and 4 months

    Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • University of Barcelona

Registry information

Official study title

BDNF as a Potential Biomarker for Cognitive Remediation Therapy in Schizophrenia

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jan 19, 2015
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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