Multicenter, Open-label, Safety and Tolerability Study



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 67
Updated:4/21/2016
Start Date:August 2009
End Date:September 2011

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A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Monotherapy in Adult Patients With Schizophrenia

This will be a multicenter, 52 week, open label study to assess the safety and tolerability
of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study
will be conducted on an outpatient basis. Enrollment into the study will be drawn from
eligible subjects who have completed participation in Study 331-07- 203 and who, in the
investigator's judgment, would benefit from continued treatment with oral OPC-34712.


Inclusion Criteria:

1. Subjects who participated in 331-07-203 and who, in the opinion of the investigator,
have the potential to benefit from continued administration of OPC-34712 for the
treatment of schizophrenia.

2. Outpatient status at last visit of Study 331-07-203.

Exclusion Criteria:

1. Sexually active males who are not practicing two different methods of birth control
during the study and for 90 days after the last dose of study medication or who will
not remain abstinent during the study and for 90 days after the last dose, or
sexually active females of childbearing potential who are not practicing two
different methods of birth control during the study and for 30 days after the last
dose of study medication or who will not remain abstinent during the study and for 30
days after the last dose. If employing birth control, two of the following
precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine
device, birth control pill, birth control depot injection, birth control implant,
condom, or sponge with spermicide.

2. Females who are breast-feeding and/or who have a positive pregnancy test result prior
to receiving open-label OPC-34712.

3. Subjects who during the course of their participation in 331-07-203 were treated in
violation of the protocol or who developed ANY exclusion criteria during the course
of their participation.

4. Subjects who do not continue to meet all applicable inclusion/exclusion criteria for
Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.

5. Subjects who represent a risk of committing suicide based on an answer of "Yes" to
either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific
Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the
"Suicidal Ideation" portion of the C-SSRS, or an answer of "Yes" to any of the
suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt,
preparatory acts or behavior) on the "Suicidal Behavior" portion of the C-SSRS. A
subject who has had any suicidal ideation within the last 6 months, any suicidal
behaviors within the last two years, or who in the clinical judgment of the
investigator presents a serious risk of suicide should be excluded from the study.

6. Subjects who would be likely to require prohibited concomitant therapy during the
study.

7. Any subject who, in the opinion of the investigator, should not participate in the
study.
We found this trial at
16
sites
Washington, District of Columbia 20010
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Austin, Texas 78754
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Austin, TX
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Bradenton, Florida 34208
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Bradenton, FL
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Burgas,
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Cedarhurst, New York 11516
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Cedarhurst, NY
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Escondido, California 92025
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Escondido, CA
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Garden Grove, California 92845
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Garden Grove, CA
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Little Rock, Arkansas 72211
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Little Rock, AR
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Long Beach, California 90806
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Long Beach, CA
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Maitland, Florida 32751
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Maitland, FL
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Oceanside, California 92056
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Oceanside, CA
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Pasadena, California 91106
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Pasadena, CA
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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San Diego, California 92102
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San Diego, CA
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Santa Ana, California 92701
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Santa Ana, CA
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St. Louis, Missouri 63110
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St. Louis, MO
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