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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Cognitive Remediation Therapy Behavioral: Psychoeducation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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)
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
- 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).
- 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
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
|Hospital Clínic Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Rafael Penadés, Ph.D.||Hospital Clinic of Barcelona|