Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia — CIDAR-3  

Schizophrenia Clinical Trial

Official title: Oxytocin or Galantamine vs. Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Schizophrenia

• NCT number: NCT01012167
• Study type: Interventional
• Source: University of Maryland, Baltimore
• Status: Completed
• Phase: Phase 2
• Start date: February 2010
• Completion date: July 2014