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Phase 2 Completed N=80 Randomized Quadruple-blind Health Services Research

Biomarker Strategies for Medication-Enhanced Cognitive Training in Schizophrenia

Source: ClinicalTrials.gov NCT01555697 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Prepulse Inhibition — 30.4; 25.5; 23.7; 2.6 % inhibition of startle

Summary

Cognitive training is moderately effective at reducing symptoms and improving life function in schizophrenia patients. The present application develops a strategy for increasing the effectiveness of cognitive training through the use of pro-cognitive medications. Specific biomarkers will be studied that identify patients most sensitive to these pro-cognitive medications, to test the feasibility of using these biomarkers in a large clinical trial of medication-enhanced cognitive training in schizophrenia.

Outcome Measures

OutcomeResultp-value
PRIMARY
Prepulse Inhibition
30.4; 25.5; 23.7; 2.6; -1.7; -9.7
SECONDARY
MATRICS
40.4; 53.4; 41.1; 56.3; 34.2; 48.6

Eligibility Criteria

Inclusion Criteria

  • A diagnosis of schizophrenia or schizoaffective disorder - depressed type

Exclusion Criteria

  • Age range,
  • Current alcohol or drug abuse
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01555697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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