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Awarded Trial: 21T-003
Grant ID
21T-003
Illness
Schizophrenia
Primary Drug/Intervention
Clemastine
Primary Dosage
8 mg/day
Secondary Drug Intervention
aerobic exercise (endurance training) add-on to standard antipsychotic treatment
Secondary Dosage
3 times per week (training sessions will last 40 minutes in weeks 1-2, 45 minutes in week 3-4 and 50 minutes in weeks 5-13
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Preparing to enroll
Investigator
Peter Falkai
Sample Size
93
Duration of Study Period for Each Subject
90 days with additional follow-up after 180 days
Outcome Measurements
Primary efficacy endpoint 1: Change in working memory performance assessed by the n-back test from the start of the intervention period (V1) to after 90-93 days of treatment (V2) Primary efficacy endpoint 2: Change in Global Assessment of Functioning (GAF) from V1 to V2 Secondary endpoints: Both primary efficacy endpoints at day 180-183, other measures of cognition, PANSS, Social Adjustment Scale, Physical fitness, Pysical activity, standard metabolic parameters, shortening of P100 latency delay on VEPs, 3T MRI at V1 and V2
Results
N/A
Publication
N/A
Link
N/A
PI Name
Peter Falkai
Degree
N/A
Center
Department of Psychiatry and Psycotherapy
Institution
Ludwig-Maximilians-University Munich
Address
NuBbaumstrasse 7
City or Town
Munchen
State or Province
N/A
Zip or Postal Code
80336
Country
Germany
Email Address
Peter.Falkai@med.uni-muenchen.de