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Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia (CIDAR-3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Maryland
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Carpenter, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01012167
First received: April 28, 2009
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.

Condition Intervention Phase
Schizophrenia
Drug: Oxytocin
Drug: Galantamine or placebo Galantamine
Drug: Placebo
Phase 2

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
Official Title: Oxytocin or Galantamine vs. Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Scale for the Assessment of Negative Symptoms (SANS) total score [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
  • Neurocognitive assessment battery composite score [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • P-50 Testing [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ] [ Designated as safety issue: No ]
  • Eye Tracking measures [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ] [ Designated as safety issue: No ]
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: Yes ]
  • Calgary Depression Scale (CDS) [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impressions (CGI) [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: Yes ]
  • Arizona Sexual Experience Questionnaire ASEX [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ] [ Designated as safety issue: No ]
  • Likert-type Scale for Social Engagement [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ] [ Designated as safety issue: No ]
  • Simpson-Angus Scale (SAS) [ Time Frame: Baseline, week 3, and week 6 ] [ Designated as safety issue: Yes ]
  • MPRC-TD scale [ Time Frame: Baseline, week 3, and week 6 ] [ Designated as safety issue: Yes ]
  • Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, week 3, and week 6 ] [ Designated as safety issue: Yes ]
  • Fagerstrom Test of Nicotine Dependence (FTND) [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ] [ Designated as safety issue: No ]
  • Side Effect Checklist (SEC) [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: Yes ]
  • EKG [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ] [ Designated as safety issue: Yes ]
  • Laboratory measures [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: February 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: Oxytocin Drug: Oxytocin
24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
Active Comparator: 2: Galantamine Drug: Galantamine or placebo Galantamine
Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
Placebo Comparator: 3: Placebo Drug: Placebo
placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012167

Contacts
Contact: Jennifer Osing, M.A. 410-402-6060 josing@mprc.umaryland.edu
Contact: Christine Brown 410-402-7878 cbrown@mprc.umaryland.edu

Locations
United States, Maryland
Baltimore VA Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kimberly Sauer    410-637-1427    Kimberly.Sauer@va.gov   
Principal Investigator: Robert W Buchanan, M.D.         
Community Mental Health Centers Recruiting
Baltimore, Maryland, United States, 21201
Contact: Alec Duggan    410-402-7205    aduggan@mprc.umaryland.edu   
Principal Investigator: Guni Thaker, M.D.         
Keypoint Community Mental Health Centers Recruiting
Baltimore, Maryland, United States, 21222
Contact: Alec Duggan    410-402-7205    aduggan@mprc.umaryland.edu   
Principal Investigator: Robert W Buchanan, M.D.         
Maryland Psychiatric Research Center Recruiting
Baltimore, Maryland, United States, 21228
Contact: Christine Brown    410-402-7878    cbrown@mprc.umaryland.edu   
Maryland Psychiatric Research Center Recruiting
Catonsville, Maryland, United States, 21228
Contact: Kelli Sullivan    410-402-6412    ksullivan@mprc.umaryland.edu   
Principal Investigator: Robert Buchanan, M.D.         
Sub-Investigator: Ikwunga Wonodi, M.D.         
Sub-Investigator: L. E. Hong, M.D.         
Principal Investigator: William T Carpenter, MD         
Principal Investigator: James Gold, PhD         
Principal Investigator: Deanna Kelly, PharmD         
Keypoint Mental health Center Recruiting
Dundalk, Maryland, United States, 21222
Contact: Alec Duggan    410-402-7205    aduggan@mprc.umaryland.edu   
Principal Investigator: Robert W Buchanan, M.D.         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: William T Carpenter, M.D. University of Maryland
  More Information

No publications provided

Responsible Party: William Carpenter, MD, Director, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland
ClinicalTrials.gov Identifier: NCT01012167     History of Changes
Other Study ID Numbers: HP-00044324, 1P50MH082999-01
Study First Received: April 28, 2009
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Schizophrenia, oxytocin, galantamine

Additional relevant MeSH terms:
Cognition Disorders
Schizophrenia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Galantamine
Oxytocin
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Oxytocics
Parasympathomimetics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014