Clinical trial NCT01776112: Enhancing Synaptic Plasticity and Cognition in Schizophrenia
Official title: Enhancing Synaptic Plasticity and Cognition by Physical Exercise and Cognitive Training in Schizophrenia: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
negative symptoms
cognitive deficits
synaptic plasticity
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hippocampal volume
timeFrame: after three months of exercise
Secondary outcomes:
measure: Verbal Learning Memory
timeFrame: after three months of exercise
measure: Positive and negative symptoms
timeFrame: after three months of exercise
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: Dept. of Psychiatry and Psychotherapy, University Medical Center Goettingen, Georg-August-University
state: Lower Saxony
Study officials:
affiliation: 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
name: Peter Falkai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Andrea Schmitt, MD, PhD
role: STUDY_DIRECTOR
affiliation: 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
name: Berend Malchow, MD
role: STUDY_DIRECTOR
References:
citation: 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.