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

• Sponsor: David C. Henderson, MD (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00975611
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC (Industry)
• Enrollment: 6
• Location: 1
• Arms: 3
• Duration (Months): 27
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: Amantadine Hydrochloride, USP; Drug: Amantadine Hydrochloride, USP; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Amantadine 100mg BID Subjects take amantadine 100mg tablets twice per day (BID)	Drug: Amantadine Hydrochloride, USP; amantadine tablets 100 mg. BID for 4 weeks; Other Names: Symmetrel
Active Comparator: Amantadine, 200mg BID Subjects take amantadine 200mg tablets twice per day (BID)	Drug: Amantadine Hydrochloride, USP; amantadine 200 mg. tablets BID for 4 weeks; Other Names: Symmetrel
Placebo Comparator: Amantadine, placebo BID Subjects take placebo tablets twice per day (BID)	Drug: Placebo; tablets BID, for 4 weeks; Other Names: Symmetrel placebo

Outcome Measures

Primary Outcome Measures

1. Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo. [week 4 and week 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Freedom Trail Clinic	Boston	Massachusetts	United States	02459

Sponsors and Collaborators

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

Investigators

• Principal Investigator: David C. Henderson, M.D., North Sufflok Mental Health Association, Freedom Trail Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David C. Henderson, MD, Associate Professor, North Suffolk Mental Health Association
• ClinicalTrials.gov Identifier: NCT00975611
• Other Study ID Numbers: R076477PD14002
• First Posted: Sep 11, 2009
• Last Update Posted: Jun 10, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by David C. Henderson, MD, Associate Professor, North Suffolk Mental Health Association: schizophrenia; schizoaffective disorder; paliperidone ER; risperidone Consta; prolactin; hyperprolactinemia
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Amantadine

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the Freedom Trail Clinic, MGH Schizophrenia Program
Pre-assignment Detail	Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen failed due to a positive drug screen.

Arm/Group Title	All Consented Subjects
Arm/Group Description	Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here.
Period Title: Overall Study
STARTED	22
COMPLETED	5
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	All Consented Subjects
Arm/Group Description	Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
Overall Participants	22
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	22 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.14 (10.95)
Sex: Female, Male (Count of Participants)
Female	7 31.8%
Male	15 68.2%
Region of Enrollment (participants) [Number]
United States	22 100%

Outcome Measures

1. Primary Outcome

Title	Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
Time Frame	week 4 and week 8

Outcome Measure Data

Analysis Population Description

Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Only baseline characteristics of all 22 consented/screened subjects were published and are reported here.

Arm/Group Title	All Consented Subjects
Arm/Group Description
Measure Participants	0

Adverse Events

Time Frame	entire study
Arm/Group Title	All Consented Subjects
Arm/Group Description	Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
All Cause Mortality
	All Consented Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Consented Subjects
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	All Consented Subjects
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.