NCT01701609

Brief Summary

Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia improving functional outcome. But most of the studies have involved participants who are in average in their mid 30s, and little is known about the efficacy of CRT in adolescents with early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in improving cognitive performance and functional outcome in adolescents with EOS. We expect to find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2007

Longer than P75 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, 2007

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

5.9 years

First QC Date

October 3, 2012

Last Update Submit

August 9, 2018

Conditions

Schizophrenia

Keywords

early-onset schizophreniaadolescentscognitioncognitive remediation therapy

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

    Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation

    20 weeks

Secondary Outcomes (2)

  • Functional outcome

    20 weeks

  • Symptoms

    20 weeks

Study Arms (1)

Cognitive Remediation Therapy

EXPERIMENTAL

CRT: Frontal/Executive Program. The program has a duration of 40 sessions, with two session for week. Is is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding in a context of learning without errors.

Behavioral: Cognitive Remediation Therapy

Interventions

Cognitive Remediation TherapyBEHAVIORAL
Also known as: Cognitive training, Cognitive enhancement
Cognitive Remediation Therapy

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age between 12 and 18 years
  • a DSM-IV-TR schizophrenia-type disorder (schizophrenia or schizoaffective disorder), with onset before the age of 17
  • being clinically and pharmacologically stabilized during the last 6 weeks before the baseline assessment
  • the estimation of not modifying pharmacological antipsychotic treatment
  • presence of cognitive deficit confirmed by the neuropsychological battery

You may not qualify if:

  • IQ below 70
  • presence of an active misuse disorder
  • presence of organic brain syndromes or neurological disorders
  • having received electroconvulsive therapy in the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child and Adolescent Pyshicatry and Psychology

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

  • Puig O, Penades R, Baeza I, De la Serna E, Sanchez-Gistau V, Bernardo M, Castro-Fornieles J. Cognitive remediation therapy in adolescents with early-onset schizophrenia: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):859-68. doi: 10.1016/j.jaac.2014.05.012. Epub 2014 Jun 21.

    PMID: 25062593RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Olga Puig, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Rafael Penadés, PhD

    Hospital Clinic of Barcelona

    STUDY DIRECTOR

  • Josefina Castro-Fornieles, MD

    Hospital Clinic of Barcelona

    STUDY DIRECTOR

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
Olga Puig Navarro

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

January 1, 2007

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

ES(1)