Clinical trial NCT01012167
Conditions: Schizophrenia
Keywords: Schizophrenia, oxytocin, galantamine
Sponsor: University of Maryland, Baltimore
Start date: 2010-02-01; Completion date: 2014-07-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:

Arms: arm 1: Subjects randomized to galantamine will receive galantamine and placebo-oxytocin arm 2: Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine arm 3: Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Interventions: intervention 1: Oxytocin intervention 2: Galantamine intervention 3: Placebo-Oxytocin intervention 4: Placebo-Galantamine
Intervention descriptions: intervention 1: 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 intervention 2: 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 intervention 3: Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration intervention 4: Placebo tablets twice a day for 6 weeks

Protocol documents: