Cognitive Remediation Therapy in Schizophrenia: Effects on BDNF Levels

Schizophrenia Clinical Trial

Official title:

BDNF as a Potential Biomarker for Cognitive Remediation Therapy in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341131
• Other study ID #: PI 11/01958
• Status: Completed
• Phase: N/A
• First received: January 8, 2015
• Last updated: February 15, 2017
• Start date: January 2012
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clínic Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BDNF (change from baseline serum BDNF levels)	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	Symptoms (Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores)	Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores at time 16 weeks	Baseline and 4 months