Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 2/7/2015 |
| Start Date: | February 2010 |
| End Date: | March 2015 |
| Contact: | Jennifer Osing, M.A. |
| Email: | josing@mprc.umaryland.edu |
| Phone: | 410-402-6060 |
Oxytocin or Galantamine vs. 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 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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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