Status:
TERMINATED
Galantamine and Memantine Combination for Cognitive Impairments in Schizophrenia
Lead Sponsor:
Sheppard Pratt Health System
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 me...
Eligibility Criteria
Inclusion
- Be male or female aged 18 to 55 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
- 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 and tobacco) 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 or unusual thought content.
- Have more than a "moderate" severity rating on the BPRS item conceptual disorganization .
- Are currently taking 3 or more antipsychotic medications.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02234752
Start Date
September 1 2014
End Date
July 1 2016
Last Update
November 9 2017
Active Locations (1)
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1
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204