Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia

NCT00509067 | Completed Phase 2 Results

• 2 other identifiers: R34MH077849DATR A5-ETBD
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of galantamine and CDP-choline in improving symptoms associated with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizoaffective Disorder; Acetylcholine; Nicotinic Receptors; Nicotine; Galantamine; negative symptoms

Outcome Measures

Primary Outcomes (1)

• Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)

  The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.

  Measured at Baseline and Weeks 4, 8, 12, and 16

Secondary Outcomes (2)

• Clinical Global Impression

  Measured at Baseline and Weeks 4, 8, 12, and 16

• MATRICS Verbal Learning and Memory

  Measured at Baseline and Weeks 8 and 16

Study Arms (2)

A

EXPERIMENTAL

Participants assigned to receive galantamine and CDP-choline

Drug: Galantamine; Drug: CDP-choline; Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole

B

PLACEBO COMPARATOR

Participants assigned to receive placebo

Drug: Placebo; Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole

Interventions

risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole DRUG

All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.

A; B

Galantamine DRUG

Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.

Also known as: Razadyne

A

CDP-choline DRUG

CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.

A

Placebo DRUG

The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
• Eligible for care within the Veterans Affairs Medical system
• Taking risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole (oral or injection)

You may not qualify if:

• Significant liver, kidney, lung, endocrine, active peptic ulcer, or cardiovascular disease
• Seizure disorder and/or head injury
• Substance use or abuse within 3 months of study entry
• Pregnant

Sponsors & Collaborators

• Georgetown University: lead
• National Institute of Mental Health (NIMH): collaborator
• Washington D.C. Veterans Affairs Medical Center: collaborator

Study Sites (1)

Washington Veterans Affairs Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Related Publications (4)

• Deutsch SI, Schwartz BL, Schooler NR, Rosse RB, Mastropaolo J, Gaskins B. First administration of cytidine diphosphocholine and galantamine in schizophrenia: a sustained alpha7 nicotinic agonist strategy. Clin Neuropharmacol. 2008 Jan-Feb;31(1):34-9. doi: 10.1097/wnf.0b013e31806462ba.

  PMID: 18303489 BACKGROUND

• Deutsch SI, Rosse RB, Schwartz BL, Schooler NR, Gaskins BL, Long KD, Mastropaolo J. Effects of CDP-choline and the combination of CDP-choline and galantamine differ in an animal model of schizophrenia: development of a selective alpha7 nicotinic acetylcholine receptor agonist strategy. Eur Neuropsychopharmacol. 2008 Feb;18(2):147-51. doi: 10.1016/j.euroneuro.2007.05.008. Epub 2007 Jul 26.

  PMID: 17656074 BACKGROUND

• Martin LF, Freedman R. Schizophrenia and the alpha7 nicotinic acetylcholine receptor. Int Rev Neurobiol. 2007;78:225-46. doi: 10.1016/S0074-7742(06)78008-4.

  PMID: 17349863 BACKGROUND

• Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.

  PMID: 16754836 BACKGROUND

Related Links

• Link for publication of study results

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Galantamine; Cytidine Diphosphate Choline; Risperidone; Olanzapine; Quetiapine Fumarate; ziprasidone; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Pyrimidinones; Benzodiazepines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Piperazines; Quinolones; Quinolines

Results Point of Contact

• Title: Dr. Stephen I. Deutsch
• Organization: Department of Psychiatry Georgetown University Medical School

DeutscSI@EVMS.EDU

757.446.5888

Study Officials

• Stephen I. Deutsch, PhD, MD

  Washington Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Dept. of Psychiatry & Behavioral Sciences, Eastern Virginia Medical School

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: July 31, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 11, 2018
• Results First Posted: February 7, 2014

Record last verified: 2018-02

Locations

US (1)