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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

Tracking Information
First Submitted Date  ICMJE January 8, 2015
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date February 17, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
BDNF (change from baseline serum BDNF levels) [ Time Frame: Baseline, 1 month and 4 months ]
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).
Change History Complete list of historical versions of study NCT02341131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Remediation Therapy in Schizophrenia: Effects on BDNF Levels
Official Title  ICMJE BDNF as a Potential Biomarker for Cognitive Remediation Therapy in Schizophrenia
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Cognitive Remediation Therapy
    Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes & Reeder, 2005)
    Intervention: Behavioral: Cognitive Remediation Therapy
  • Active Comparator: Psychoeducation
    Symptom Management Module from the University of California. Liberman & Kopelowicz (1995)
    Intervention: Behavioral: Psychoeducation
  • No Intervention: Healthy Controls
    No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2016)
70
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2015)
60
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02341131
Other Study ID Numbers  ICMJE PI 11/01958
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rafael Penades, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE University of Barcelona
Investigators  ICMJE
Principal Investigator: Rafael Penadés, Ph.D. Hospital Clinic of Barcelona
PRS Account Hospital Clinic of Barcelona
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP