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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 November 2012
• Main ID: NCT01012167
• Date of registration: 28/04/2009
• Primary sponsor: University of Maryland
• Public title: Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia CIDAR-3
• Scientific title: Oxytocin or Galantamine vs. Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
• Date of first enrolment: February 2010
• Target sample size: 140
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01012167
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jennifer Osing, M.A.

• Name: William T Carpenter, M.D.
• Affiliation: University of Maryland

Key inclusion & exclusion criteria

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 affective flattening OR SANS alogia global item scores 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 current alcohol or substance dependence (other than
nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse
(other than nicotine) within the last month.

- Participants with a DSM-IV diagnosis of Major Depressive Disorder within last 6
months will also be excluded.

- Participants may be treated with one or more antipsychotics, except clozapine,
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 treated with
olanzapine doses greater than 20 mg will be also excluded, because of concerns about
its anticholinergic properties at higher doses.

- Participants may not be treated with anticholinergic medications or have clinically
significant extrapyramidal symptoms.

- Female participants who are pregnant, planning to become pregnant or breastfeeding
will be excluded since oxytocin may induce labor. In addition, women of childbearing
age are required to use an effective form of birth control for the duration of the
study. Effective forms of birth control include:

1. hormonal contraceptives (birth control pills, injectable hormones, vaginal ring
hormones),

2. surgical sterility (tubal ligation or hysterectomy)

3. IUD

4. Diaphragm with spermicide

5. Condom with spermicide

- Participants will not have been randomized to Galantamine in a previous clinical
trial at the Maryland Psychiatric Research Center



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Galantamine or placebo Galantamine

Drug: Oxytocin

Drug: Placebo

Primary Outcome(s)

Neurocognitive assessment battery composite score [Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment]

Scale for the Assessment of Negative Symptoms (SANS) total score [Time Frame: Weekly for 6 weeks]

Secondary Outcome(s)

Arizona Sexual Experience Questionnaire ASEX [Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment]

Barnes Akathisia Scale (BAS) [Time Frame: Baseline, week 3, and week 6]

Brief Psychiatric Rating Scale (BPRS) [Time Frame: Weekly for 6 weeks]

Calgary Depression Scale (CDS) [Time Frame: Weekly for 6 weeks]

Clinical Global Impressions (CGI) [Time Frame: Weekly for 6 weeks]

EKG [Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment]

Eye Tracking measures [Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment]

Fagerstrom Test of Nicotine Dependence (FTND) [Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment]

Laboratory measures [Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment]

Likert-type Scale for Social Engagement [Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment]

MPRC-TD scale [Time Frame: Baseline, week 3, and week 6]

P-50 Testing [Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment]

Side Effect Checklist (SEC) [Time Frame: Weekly for 6 weeks]

Simpson-Angus Scale (SAS) [Time Frame: Baseline, week 3, and week 6]

Vital Signs [Time Frame: Weekly for 6 weeks]

Secondary ID(s)

1P50MH082999-01

HP-00044324

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Mental Health (NIMH)