NCT02341131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

3.9 years

First QC Date

January 8, 2015

Last Update Submit

February 15, 2017

Conditions

Schizophrenia

Keywords

SchizophreniaCognitive RemediationBDNF

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Symptoms (Change from baseline in Positive and Negative Syndrome Scale (PANSS) scores)

    Baseline and 4 months

Study Arms (3)

Cognitive Remediation Therapy

EXPERIMENTAL

Cognitive Remediation Therapy -Frontal/Executive Program (Delahunty)- (Wykes \& Reeder, 2005)

Behavioral: Cognitive Remediation Therapy

Psychoeducation

ACTIVE COMPARATOR

Symptom Management Module from the University of California. Liberman \& Kopelowicz (1995)

Behavioral: Psychoeducation

Healthy Controls

NO INTERVENTION

No intervention

Interventions

Cognitive Remediation TherapyBEHAVIORAL

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.

Also known as: Cognitive rehabilitation, cognitive training
Cognitive Remediation Therapy
PsychoeducationBEHAVIORAL

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.

Also known as: Coping strategies, skills training
Psychoeducation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of organic-cerebral affectation due to neurological or traumatic conditions
  • Abuse of psychotropic substances
  • Presence of other psychiatric symptomatology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • Penades R, Segura B, Inguanzo A, Garcia-Rizo C, Catalan R, Masana G, Bernardo M, Junque C. Cognitive remediation and brain connectivity: A resting-state fMRI study in patients with schizophrenia. Psychiatry Res Neuroimaging. 2020 Sep 30;303:111140. doi: 10.1016/j.pscychresns.2020.111140. Epub 2020 Jul 15.

    PMID: 32693320DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive TrainingCoping Skills

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rafael Penadés, Ph.D.

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 19, 2015

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

ES(1)