Cognitive Remediation Therapy in Schizophrenia: Effects on BDNF Levels
February 15, 2017 updated by: Rafael Penades, Hospital Clinic of Barcelona
BDNF as a Potential Biomarker for Cognitive Remediation Therapy in Schizophrenia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08036
- Hospital Clinic Barcelona
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Remediation Therapy
Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes & Reeder, 2005)
|
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:
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Active Comparator: Psychoeducation
Symptom Management Module from the University of California.
Liberman & Kopelowicz (1995)
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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:
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No Intervention: Healthy Controls
No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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BDNF (change from baseline serum BDNF levels)
Time Frame: Baseline, 1 month and 4 months
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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).
|
Baseline, 1 month and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and 4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
January 8, 2015
First Submitted That Met QC Criteria
January 13, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Actual)
February 17, 2017
Last Update Submitted That Met QC Criteria
February 15, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI 11/01958
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.