Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation

NCT00975611 | Terminated Phase 4 Results

• 1 other identifier: R076477PD14002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to show that amantadine might help to reduce the side effect of the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be developed in patients treated with the paliperidone ER or risperidone Consta. High level of prolactin might stimulate breast development, might decrease sexual desire (libido). The goals of this study are to demonstrate that amantadine lowers prolactin levels, decreases side effects, and improves psychiatric symptoms.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; schizoaffective disorder; paliperidone ER; risperidone Consta; prolactin; hyperprolactinemia

Outcome Measures

Primary Outcomes (1)

• Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.

  week 4 and week 8

Study Arms (3)

Amantadine 100mg BID

ACTIVE COMPARATOR

Subjects take amantadine 100mg tablets twice per day (BID)

Drug: Amantadine Hydrochloride, USP

Amantadine, 200mg BID

ACTIVE COMPARATOR

Subjects take amantadine 200mg tablets twice per day (BID)

Drug: Amantadine Hydrochloride, USP

Amantadine, placebo BID

PLACEBO COMPARATOR

Subjects take placebo tablets twice per day (BID)

Drug: Placebo

Interventions

Amantadine Hydrochloride, USP DRUG

amantadine tablets 100 mg. BID for 4 weeks

Also known as: Symmetrel

Amantadine 100mg BID

Placebo DRUG

tablets BID, for 4 weeks

Also known as: Symmetrel placebo

Amantadine, placebo BID

Eligibility Criteria

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

You may qualify if:

• Male or female
• Age 18-65 years
• Diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
• Well established compliance with out-patient medications including paliperidone ER or risperidone Consta for 3 months

You may not qualify if:

• Current substance or alcohol abuse
• Significant medical illness
• Women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
• Subjects treated with more than one antipsychotic drug

Sponsors & Collaborators

• David C. Henderson, MD: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Hyperprolactinemia

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Too few subjects met study's eligibility criteria to run statistical analyses on primary outcomes. The baseline demographic data are reported here. Future research is needed to understand the prevalence of elevated prolactin in schizophrenia.

Results Point of Contact

• Title: Dr. David Henderson
• Organization: Massachusetts General Hospital Schizophrenia Research Program

dchenderson@partners.org

(617) 912-7800

Study Officials

• David C. Henderson, M.D.

  North Sufflok Mental Health Association, Freedom Trail Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 10, 2013
• Results First Posted: June 10, 2013

Record last verified: 2013-01

Locations

US (1)