Enhancing Synaptic Plasticity and Cognition in Schizophrenia

NCT01776112 | Completed

• 1 other identifier: UMCG-EX-II
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

schizophrenia; negative symptoms; cognitive deficits; synaptic plasticity

Outcome Measures

Primary Outcomes (1)

• Hippocampal volume

  Measurement of hippocampal volume before and after the exercise intervention, 3T-MRI MPRAGE-Sequence, manual and automated delineation of hippocampal borders

  after three months of exercise

Secondary Outcomes (2)

• Verbal Learning Memory

  after three months of exercise

• Positive and negative symptoms

  after three months of exercise

Study Arms (3)

SZ-Exercise

EXPERIMENTAL

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.

Other: Exercise

SZ-TableSoccer

PLACEBO COMPARATOR

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.

Other: TableSoccer

HC-Exercise

EXPERIMENTAL

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.

Other: Exercise

Interventions

Exercise 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.

HC-Exercise; SZ-Exercise

TableSoccer 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.

SZ-TableSoccer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University

Göttingen, Lower Saxony, 37075, Germany

Location

Related Publications (1)

• Pajonk FG, Wobrock T, Gruber O, Scherk H, Berner D, Kaizl I, Kierer A, Muller S, Oest M, Meyer T, Backens M, Schneider-Axmann T, Thornton AE, Honer WG, Falkai P. Hippocampal plasticity in response to exercise in schizophrenia. Arch Gen Psychiatry. 2010 Feb;67(2):133-43. doi: 10.1001/archgenpsychiatry.2009.193.

  PMID: 20124113 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Peter Falkai, MD, PhD

  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

  PRINCIPAL INVESTIGATOR

• Andrea Schmitt, MD, PhD

  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

  STUDY DIRECTOR

• Berend Malchow, MD

  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

  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: Prof. Dr. med. Peter Falkai

Study Record Dates

• First Submitted: January 1, 2012
• First Posted: January 25, 2013
• Study Start: January 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

DE (1)