EVP-6124 as a treatment to improve mental function in Schizophrenia
- Conditions
- Cognitive impairment associated with schizophreniaMedDRA version: 18.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disordersMedDRA version: 18.1 Level: LLT Classification code 10009846 Term: Cognitive impairment System Organ Class: 100000004852Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-003209-92-GB
- Lead Sponsor
- Forum Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 766
1.Signed informed consent, indicating that the subject understands the purpose of and procedures required for the study, before the initiation of any study specific procedures. Subjects who are unable to provide informed consent will not be included in the study
2.Signed acknowledgment of responsibilities by an identified informant before the initiation of any activities required by the study for the designated informant
3.Male or female subjects of any race; between 18 to 50 years of age, inclusive
4.Resides in a stable living situation, according to the investigator’s judgment, and must have an identified informant who should be consistent throughout the study. If possible, the informant should accompany the subject or be available for in person ratings at the screening, baseline (Day 1) and final study visits. In person informant ratings on all relevant study visits are preferred whenever possible. However, if the informant is not available for in person ratings, telephone interview is acceptable. The informant must be available for a telephone interview throughout the study at all visits. As long as both the informant visit and subject visit are within the study visit windows, it is not necessary that they occur on the same day. The informant must interact with the subject at least 2 times a week.
5.Diagnosis of Schizophrenia of at least 3 years duration established by utilizing the SCID-I, direct clinical assessments, family, informants, and confirmation of diagnosis from clinical sources (medical records, confirmation of diagnosis by treating clinician through telephone contact, written confirmation from treating clinic, or other sources of diagnostic confirmation may also be acceptable after discussion with the medical monitor).
6.(Schizophrenia) illness in a nonacute (eg, chronic) phase as determined by their primary treating clinician
7.Treated with an atypical antipsychotic drug (in any approved dosage form) other than clozapine at a stable dose for at least 8 weeks before screening and be clinically stable; the subject must remain clinically stable (in the opinion of the principal investigator) through randomization. The use of up to 2 atypical antipsychotic drugs is permitted, as long as in the opinion of the investigator, the second medication is not required to control treatment-resistant or intractable psychotic symptoms. No subject will be washed off antipsychotic therapy to become eligible for this study.
8.Schizophrenia clinical symptom burden severity defined by the following: a Brief Psychiatric Rating Scale (BPRS) Conceptual Disorganization item score = 4; and, a BPRS Hallucinatory Behavior item score = 5, or an Unusual Thought Content item score = 5. Either Hallucinatory Behavior or Unusual Thought Content, but not both, may have a score of 6 (but not > 6).
9.A minimal level of EPS; SAS total score = 6
10.A minimal level of depression; CDSS total score = 10
11.General health status acceptable for participation in a 26-week clinical study
12.Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1 y
1.Violation of any inclusion criteria
2.Failure to perform screening or baseline examinations
3.Hospitalization within 12 weeks before screening or during the screening period, or change of antipsychotic medication or dose within 8 weeks before screening or during the screening period (Section 8.1)
4.Psychiatric hospitalization or incarcerations due to breakthrough symptoms or acute exacerbations for a period of 3 months before screening. Subjects with a recent social” hospitalization or incarceration may be entered into screening after consultation with the medical monitor
5.Participation in another therapeutic (medication administration) clinical study within the past 2 months
6.Likelihood, in the opinion of the investigator, that either the subject or informant will be unable to complete a 26-week study
7.Serum electrolytes (sodium, potassium, and magnesium) clinically significantly abnormal
8.Insufficiently controlled diabetes mellitus in the judgment of the investigator
9.Renal insufficiency with serum creatinine > 1.8 mg/dL
10.Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma in situ
11.Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study
12.Unstable medical condition that is clinically significant in the judgment of the investigator
13.Body mass index (BMI) of > 38 kg/m2
14.History of myocardial infarction or unstable angina within the last 3 months before screening
15.Cardiovascular disease history; including uncontrolled hypotension or hypertension, that is clinically significant in the judgment of the investigator
16.Clinically significant abnormality on screening or baseline (pre-dose Day 1) ECG, including but not necessarily limited to a confirmed QTc value = 450 msec for males or = 470 msec for females
17.Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5 times the upper limit of normal (ULN)
18.Treatment with prohibited antipsychotic drug, and/or treatment with more than 2 permitted antipsychotic drugs. Treatment with a first generation antipsychotic drug (typical antipsychotic) is prohibited unless it is administered at a low dose after discussion with the medical monitor.
19.Current treatment with any anticholinergic agent
20.Subjects with other DSM-IV-TR Axis I or Axis II disorders are ineligible if the comorbid condition is clinically unstable or has been the focus of treatment in the past 3 months
21.DSM-IV criteria for alcohol abuse within the past 3 months or substance abuse (other than nicotine) within the last 6 months before screening
22.Significant suicide risk as defined by 1) suicidal ideation as endorsed on items 4 and 5 of the C-SSRS within the past 2 years) suicidal behaviors detected by the C SSRS during the past 2 years; or 3) psychiatric interview and examination
23.Subjects planning to initiate a new course of cognitive remediation or psychotherapy during the study period including cognitive and cognitive-behavioral therapies. Subjects who have been receiving individual or group therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method