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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Amantadine Hydrochloride, USP

Placebo

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorder, paliperidone ER, risperidone Consta, prolactin, hyperprolactinemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Freedom Trail Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Amantadine 100mg BID

Amantadine, 200mg BID

Amantadine, placebo BID

Arm Description

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

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

Subjects take placebo tablets twice per day (BID)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00975611

First Posted

September 10, 2009

Last Updated

May 3, 2013

Sponsor

David C. Henderson, MD

Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00975611

Brief Title

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

Official Title

Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Terminated

Why Stopped

The sponsor withdrew support due to slow accrual of eligible subjects.

Study Start Date

October 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

David C. Henderson, MD

Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Trial Description: A double-blind, placebo-controlled, prospective, randomized trial to evaluate the effects of two doses of amantadine or placebo in the management of antipsychotic-induced hyperprolactinemia and psychiatric status in patients with schizophrenia or schizoaffective disorder who are clinically stable on paliperidone ER or risperidone Consta. Placebo or amantadine 100 mg or 200 mg BID will be administered to participants for 4 consecutive weeks as an adjunctive therapy in 72 schizophrenia subjects treated with paliperidone or risperidone Consta to examine amantadine effects on fasting AM serum prolactin levels. Participants will be followed after suspension of amantadine or placebo for an additional 4 weeks for safety purposes. The goals of this study are to prospectively demonstrate that amantadine lowers prolactin levels, and evaluate the impact of amantadine on psychiatric symptoms, and on prolactin-related side effects in patients treated with paliperidone ER or risperidone Consta.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amantadine 100mg BID

Arm Type

Active Comparator

Arm Description

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

Arm Title

Amantadine, 200mg BID

Arm Type

Active Comparator

Arm Description

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

Arm Title

Amantadine, placebo BID

Arm Type

Placebo Comparator

Arm Description

Subjects take placebo tablets twice per day (BID)

Intervention Type

Drug

Intervention Name(s)

Amantadine Hydrochloride, USP

Other Intervention Name(s)

Symmetrel

Intervention Description

amantadine tablets 100 mg. BID for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Amantadine Hydrochloride, USP

Other Intervention Name(s)

Symmetrel

Intervention Description

amantadine 200 mg. tablets BID for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Symmetrel placebo

Intervention Description

tablets BID, for 4 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

week 4 and week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David C. Henderson, M.D.

Organizational Affiliation

North Sufflok Mental Health Association, Freedom Trail Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Freedom Trail Clinic

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02459

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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