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NCT01012167 · ClinicalTrials.gov registry record · Phase 2
Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
A Phase 2 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT01012167 is a Phase 2 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 86 participants.
The verdict
NCT01012167, a Phase 2 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study 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
Interventions
- DRUG Oxytocin
- DRUG Galantamine
- OTHER Placebo-Oxytocin
- OTHER Placebo-Galantamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2010-02 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01012167
The ClinicalTrials.gov registry entry for NCT01012167 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Oxytocin is the first listed.
NCT01012167 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01012167 about?
NCT01012167 is a clinical study titled "Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia". 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 ...
What is the current status of trial NCT01012167?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2010-02. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01012167?
The interventions under investigation include: Oxytocin (DRUG), Galantamine (DRUG), Placebo-Oxytocin (OTHER), Placebo-Galantamine (OTHER).
Who is sponsoring clinical trial NCT01012167?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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