Enhancing Synaptic Plasticity and Cognition in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-08-31

Brief Summary

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To explore: (a) if physical exercise (sports) combined with cognitive training leads to (superior) improvement of cognition in schizophrenia compared to sports or cognitive training alone (b) if a sports program alone or in combination with cognitive training has influence on hippocampal pathology and synaptic plasticity in schizophrenia compared to a placebo condition.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SZ-Exercise

Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

SZ-TableSoccer

Standard treatment and participation in an activity without physical improvement as placebo condition (table soccer in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

Group Type PLACEBO_COMPARATOR

TableSoccer

Intervention Type OTHER

Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

HC-Exercise

Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

Interventions

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Exercise

Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

Intervention Type OTHER

TableSoccer

Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male and female patients with the diagnosis of schizophrenia (based on ICD-10 criteria)
* Age between 18 and 55
* Verbal IQ ≥ 85
* Stable psychopathology on constant medication for 2 weeks
* Informed consent.

Exclusion Criteria

Patients, who are

* not willing or able to participate in the sports program and cognitive training
* reveal a significant worsening of psychopathology (based on an increase over 20% of the PANSS positive score)
* have an organic mental disorder (such as intoxication or neurological disorders of the CNS)
* suffer from instable somatic diseases
* have an active substance abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Prof. Dr. Peter Falkai

Prof. Dr. med. Peter Falkai

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Falkai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610

Andrea Schmitt, MD, PhD

Role: STUDY_DIRECTOR

Professor, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610

Berend Malchow, MD

Role: STUDY_DIRECTOR

Senior Consultant, Dept. of Psychiatry and Psychotherapy University Medical Center Goettingen Georg-August-University von-Siebold-Strasse 5 D-37075 Goettingen Germany P: +49-(0)551-39-6610