Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): Oxytocin; Galantamine; Placebo-Oxytocin; Placebo-Galantamine
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Oxytocin: 24 IU in the morning and 24 IU in the evening given by nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration; Galantamine: 4 mg twice a day for 1 week, then 8 mg twice a day for 1 week, then 12 mg twice a day for 4 weeks; Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration; Placebo tablets twice a day for 6 weeks
Intervention MeSH terms: Galantamine; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia, oxytocin, galantamine