Galantamine and Memantine for Cognitive Impairments in Schizophrenia
Information source: Sheppard Pratt Health System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Intervention: Galantamine ER (Drug); Memantine XR (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sheppard Pratt Health System Official(s) and/or principal investigator(s): Maju M. Koola, MD, Principal Investigator, Affiliation: Sheppard Pratt Health System
Overall contact: Jennifer H. Sklar, MS, Phone: 410-938-3136, Email: jsklar@sheppardpratt.org
Summary
Aim: To examine the efficacy of the combination of galantamine and memantine for the
treatment of cognitive deficits in outpatients with schizophrenia.
Hypothesis: A combination of galantamine and memantine will improve cognitive impairments in
patients with schizophrenia.
This is an open-label study to evaluate whether a six week course of galantamine ER and
memantine XR is effective in improving the cognitive performance of patients with
schizophrenia or schizoaffective disorder. The primary outcome measure will be the change in
level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). The
results of the MATRICS collaborative project recommended the need for standardized cognitive
tests that better distinguish the different facets of cognitive dysfunction in
schizophrenia. The MCCB will assess the following seven domains: attention/vigilance,
reasoning and problem solving, processing speed, social cognition, verbal learning and
memory, visual learning and memory, and working memory. The MCCB will be administered at
baseline and at the end of the study. We will report total score and each domain score in
the MCCB at baseline and six weeks.
Clinical Details
Official title: A Proof-of Concept Trial of Galantamine and Memantine for Cognitive Impairments in Schizophrenia: Is the Combination Effective?
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in level of cognition
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Be male or female aged 18 to 50 years (inclusive).
- Have a DSM-5 diagnosis of schizophrenia or schizoaffective disorder confirmed by
medical records. Duration of illness must be ≥ 1year.
- Be clinically stable for at least two months (i. e., has no more than a "moderately
severe" severity rating on the following BPRS items: hallucination, unusual thought
content and conceptual disorganization.
- Have not had a psychiatric hospitalization in the two months prior to screening.
- Be taking any 1st generation antipsychotic prescribed in the absence of a concomitant
anticholinergic or 2nd generation antipsychotic and minimal extrapyramidal symptoms
- Have a Simpson-Angus Score (SAS) < 6
- Be on current medication regimen for at least six weeks before screening at stable
dose and frequency for at least 30 days before screening.
- Be in good general health and expected to complete the clinical study as designed.
- Subjects of childbearing potential must agree to use two forms of non-hormonal
contraception (dual contraception) consistently during the screening and treatment
periods of the trial, and for 30 days after the final dose of the study medications.
- Females of child-bearing potential must have a negative urine pregnancy test at
baseline. This may also be done at subsequent visits if subject reports possibility
of pregnancy.
- Have a negative urine drug screen at screening. This may be repeated at the
discretion of the primary investigator.
- Have adequate hearing, vision, and language skills to perform the procedures
specified in the protocol.
- Be capable of providing informed consent and have voluntarily provided informed
consent.
Exclusion Criteria:
- Have an active, clinically significant unstable medical condition with 30 days prior
to screening.
- Have dementia.
- Are pregnant, breastfeeding, or planning to become pregnant
- Are taking or thinking about taking oral contraceptives or an injectable
contraceptive.
- Are taking benztropine at a dose greater than 2 mg daily.
- Have a history of Pervasive Development Disorder.
- Have a history of significant head injury/trauma (defined by one of more of the
following: loss of consciousness for more than one hour; recurring seizures
resulting from the head injury; and/or clear cognitive sequelae of the injury
requiring cognitive rehabilitation.)
- Have an allergy to anticholinesterase medications (galantamine, rivastigimine,
donepezil) and memantine
- Have a DSM-5 diagnosis of alcohol and/or substance use disorder (other than caffeine
andtobacco) within the last 6 months.
- Are taking a restricted medication: Amitriptyline, Doxepin, Imipramine, Flexeril,
Clozapine, and/or cortisol (any oral, injectable, or topical steroid medication)
- Have a history of seizures excluding a childhood febrile seizure
- Have received ECT within the last three months prior to screening.
- Have participated in a clinical trial of any other psychotropic medication within
last two months prior to screening.
- Have a "severe" or "extremely severe" severity rating on the BPRS items:
hallucination, unusual thought content and conceptual disorganization.
- Are currently taking 3 or more antipsychotic medications.
Locations and Contacts
Jennifer H. Sklar, MS, Phone: 410-938-3136, Email: jsklar@sheppardpratt.org
Sheppard Pratt Health System, Baltimore, Maryland 21204, United States; Recruiting Maju M. Koola, MD, Principal Investigator Scott T. Aaronson, MD, Sub-Investigator
Additional Information
Related publications: Koola MM, Buchanan RW, Pillai A, Aitchison KJ, Weinberger DR, Aaronson ST, Dickerson FB. Potential role of the combination of galantamine and memantine to improve cognition in schizophrenia. Schizophr Res. 2014 Aug;157(1-3):84-9. doi: 10.1016/j.schres.2014.04.037. Epub 2014 May 28. Review.
Starting date: September 2014
Last updated: June 18, 2015
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