Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
Public ClinicalTrials.gov record NCT01012167. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Oxytocin or Galantamine vs. Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01012167
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Interventions
- Oxytocin Drug
- Galantamine Drug
- Placebo-Oxytocin Other
- Placebo-Galantamine Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2010
- Primary completion
- Jun 30, 2014
- Completion
- Jun 30, 2014
- Last update posted
- Jan 11, 2022
2010 – 2014
United States locations
- U.S. sites
- 6
- U.S. states
- 1
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baltimore VA Medical Center | Baltimore | Maryland | 21201 | — |
| Community Mental Health Centers | Baltimore | Maryland | 21201 | — |
| Keypoint Community Mental Health Centers | Baltimore | Maryland | 21222 | — |
| Maryland Psychiatric Research Center | Baltimore | Maryland | 21228 | — |
| Maryland Psychiatric Research Center | Catonsville | Maryland | 21228 | — |
| Keypoint Mental health Center | Dundalk | Maryland | 21222 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01012167, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 11, 2022 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01012167 live on ClinicalTrials.gov.