Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
The project is designed to address the following two primary aims:
1. To determine whether adjunctive oxytocin is superior to placebo for the treatment of
persistent negative symptoms, as measured by the SANS total score, in people with
schizophrenia.
2. To determine whether adjunctive Galantamine is superior to placebo for the treatment of
cognitive impairments, as measured by improvement on a composite neurocognitive score in
people with schizophrenia.
The investigators will also address the following secondary aims:
1. To determine whether people with schizophrenia treated with adjunctive oxytocin,
compared to placebo, will show greater improvement on markers of negative symptom
liability including: social affiliation, facial affect recognition, olfactory
discrimination, initiation of smooth pursuit and latency of internally-driven saccades.
2. To determine whether people with schizophrenia treated with adjunctive Galantamine,
compared to placebo, will show greater improvement on markers of cognitive impairment
liability including: predictive pursuit, P50 sensory gating and visual-spatial working
memory.
The investigators will address the following exploratory aims:
1. To determine whether changes in markers of negative symptom liability are correlated
with changes in SANS total score.
2. To determine whether changes in markers of cognitive impairment liability are correlated
with changes in the composite neurocognitive score.
3. To determine the response to oxytocin of all cognition domains assessed by the MATRICS
battery, and to determine the response to Galantamine of all cognition domains assessed
by the MATRICS, which are not included in the primary neurocognitive outcome score.
4. To determine whether there is a differential response of oxytocin and Galantamine on the
SANS total score, composite neurocognitive score, and with the phenotypic measures of
negative symptom and cognitive impairment liability.
5. To determine whether oxytocin and Galantamine are associated with:
- adverse effects on positive or depressive symptoms;
- adverse effects on motor symptoms;
- adverse effects on laboratory and EKG measures;
- increased occurrence of side effects;
- social interest that is independent of sexual desire.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland University of Maryland, Baltimore