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Cognitive Remediation Therapy in Schizophrenia: Effects on BDNF Levels

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ClinicalTrials.gov Identifier: NCT02341131
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
University of Barcelona
Information provided by (Responsible Party):
Rafael Penades, Hospital Clinic of Barcelona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive Remediation Therapy Behavioral: Psychoeducation Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BDNF as a Potential Biomarker for Cognitive Remediation Therapy in Schizophrenia
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Cognitive Remediation Therapy
Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes & Reeder, 2005)
Behavioral: Cognitive Remediation Therapy
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 Name: Cognitive rehabilitation, cognitive training

Active Comparator: Psychoeducation
Symptom Management Module from the University of California. Liberman & Kopelowicz (1995)
Behavioral: Psychoeducation
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 Name: Coping strategies, skills training

No Intervention: Healthy Controls
No intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341131


Locations
Spain
Hospital Clínic Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
University of Barcelona
Investigators
Principal Investigator: Rafael Penadés, Ph.D. Hospital Clinic of Barcelona

Responsible Party: Rafael Penades, Ph.D., Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02341131     History of Changes
Other Study ID Numbers: PI 11/01958
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rafael Penades, Hospital Clinic of Barcelona:
Schizophrenia
Cognitive Remediation
BDNF

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders