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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID: NCT01012167
Run by: University of Maryland, Baltimore
People needed: 86
Starts: 2010-02-01
Expected to finish: 2014-07-01
Last updated by the study team: 2022-01-12

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Any race
Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder
Judged clinically stable and will not exceed threshold levels of positive, depressive, and/or extrapyramidal symptoms
The minimum level of negative symptoms will be defined as follows:
Scale for the Assessment of Negative Symptoms (SANS) total score (minus the global items, and inappropriate affect, poverty of content of speech and attentional items) 20 or greater; OR
SANS alogia global item score 3 or greater
The maximum level of psychotic, depressive, and extrapyramidal symptoms at the beginning and end of leading in:
Brief Psychiatric Rating Scale (BPRS) psychotic factor score (4-items) less or equal to 16
BPRS Anxiety/Depression factor score (4-items) less than or equal to 14
Simpson-Angus-Scale (SAS) total score (13-items) less than or equal to 10
Subjects will be required to be on the same antipsychotic(s) for two months and on the same dose for the last month

You may not qualify if…

Participants with an organic brain disorder; mental retardation; or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
Participants with intermittent alcohol or substance use will not be excluded unless they have met DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month.
Participants may be treated with one or more antipsychotics, except chlorpromazine, thioridazine, or mesoridazine. These latter antipsychotics are excluded because of the concern that their anticholinergic properties may interfere with the accurate assessment of galantamine efficacy.
Participants may not be treated with anticholinergic medications or have clinically significant extrapyramidal symptoms. Additionally, subjects treated with glycopyrrolate will be accepted.
Female participants may not be pregnant
Female subjects may not be taking olanzapine at doses higher than 30 mg . Male subjects may not be taking olanzapine at doses higher than 40 mg.

Where it is running

Baltimore VA Medical Center — Baltimore, Maryland, United States
Community Mental Health Centers — Baltimore, Maryland, United States
Keypoint Community Mental Health Centers — Baltimore, Maryland, United States
Maryland Psychiatric Research Center — Baltimore, Maryland, United States
Maryland Psychiatric Research Center — Catonsville, Maryland, United States
Keypoint Mental health Center — Dundalk, Maryland, United States

Full record on ClinicalTrials.gov

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