Major Depressive Disorder (MDD) MedDRA version: 8.0 Level: LLT Classification code 10025454
Conditions
Interventions
Product Name: Elzasonan
Product Code: CP-448,187-10
Pharmaceutical Form: Tablet
INN or Proposed INN: Elzasonan
CAS Number: 361343-20-6
Current Sponsor code: CP-448,187-10
Other descriptive name: See Q
Sponsors
Pfizer Ltd, Sandwich, UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult subjects, 18 years of age or older, with a diagnosis of recurrent, moderate-to-severe MDD without psychotic features (DSM IV 296.3x). 2. Subjects must have a HAMD17 score =22 and CGI-S score =4 at both the screening and Week 0 (baseline) visits. 3. Subjects must have a primary diagnosis of recurrent MDD without psychotic features by DSM IV criteria (296.3x) as confirmed by the M.I.N.I.. The current depressive episode must be at least 1 month in duration but no longer than 6 months in duration. 4. MDD must be the primary psychiatric disorder present and the condition that motivated the subject to seek treatment. Subjects with concurrent diagnoses of Dysthymic Disorder, Specific Phobia, or Social Phobia are eligible if MDD is the primary diagnosis. Subjects with a concurrent diagnosis of Generalized Anxiety Disorder (GAD) are eligible if MDD is the primary diagnosis and the current depressive episode began before GAD criteria were met. 5. Subjects must be in good health and have normal laboratory findings at screening, including thyroid function tests, except for minor divergences from normal ranges of laboratory tests determined to be clinically non-significant by the investigator. 6. Females of childbearing potential must be willing to use an acceptable method of contraception from at least 14 days prior to the Week 0 (baseline) visit until completion of follow-up procedures. 7. The subject's electrocardiogram must be without clinically significant abnormalities as determined by an internist and/or cardiologist at the screening visit. 8. Urine drug screen at screening should be negative for illicit drugs and/or protocol prohibited psychoactive substances; eg, benzodiazepines. Chronic benzodiazepine users are excluded from participating in the trial. 9. Subjects must have a Body Mass Index (BMI) of =17 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Investigators and their immediate families 2. Subjects who have ever been diagnosed with Panic Disorder, Post-Traumatic Stress Disorder (PTSD), Obsessive-Compulsive Disorder (OCD), Bipolar Affective Disorder, Schizophrenia, Schizoaffective Disorder or other Psychotic Disorder, MDD with Seasonal Pattern, or Dissociative Disorders per DSM-IV criteria. Subjects with current DSM-IV-defined Substance Abuse or Dependence 3. Subjects who have been treated with ECT or fluoxetine within 6 weeks prior to the baseline visit, who have been treated with monoamine oxidase inhibitors within 2 weeks prior to the baseline visit, any oral antipsychotics within 4 weeks prior to the baseline visit, any subjects who have previously used depot antipsychotics, and subjects who, in the investigator's judgment, would require treatment with electro-convulsive therapy, antipsychotics, would require a change in intensity of sychotherapy, or would require additional treatment with any other psychotherapeutic drugs during the trial 4. Subjects who have been treated with prescription or nonprescription psychotropic drug within 1 week prior to the baseline visit, with the exception of the protocol allowed concomitant medications 5. Subjects who have been treated with oral antipsychotics within 4 weeks prior to the baseline visit 6. Subjects who have previously participated in this trial or any other clinical trial with elzasonan or sertraline 7. Subjects with comorbid Personality Disorders (Axis II) based on DSM-IV criteria and the clinical judgment of the investigator 8. Subjects who are judged clinically to be at serious suicidal or homicidal risk 9. Subjects who in the judgment of the investigator are unable or unlikely to comprehend and/or follow the clinical trial protocol. Subjects must be able to provide and be competent to sign an informed consent form for participation in the study 10. Subjects who in the judgment of the investigator are unlikely to comply with trial medication 11. Female subjects who are pregnant or breastfeeding. Males and females unwilling to abstain from sex or comply with lifestyle guidelines in protocol 12. Subjects with a history of clinically significant and currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine, including diabetes type I and type II, pulmonary, dermatological, oncological, or neurological disease, including seizures or seizure disorders of any etiology 13. Subjects with uncorrected hypothyroidism or hyperthyroidism. Subjects requiring thyroid hormone replacement must be on a stable dose of medication for at least 2 weeks prior to the baseline visit 14. Subjects with a history of clinically significant cardiovascular disease, including hypertension, hypotension, any significant symptomatic arrhythmia, congestive heart failure, angina pectoris, cardiac bypass surgery, or recent (within the last 6 months) myocardial infarction 15. Subjects with ECG evidence of QRS >120 msec or QTc >450 msec. Additionally, subjects with clinically significant ECG abnormality at screening including conduction abnormalities or known history of QT prolongation (including congenital long QT syndrome) 16. Subjects known to be HIV positive 17. Subjects positive for hepatitis B surface antigen and/or hepatitis C antibody with liver function tests outside the normal range. 18. Subjects with known allergy to elzasonan or sertraline, or their excipients 19. Subjects with any medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of the administration of sertraline and elzasonan combination (SEC) to sertraline monotherapy in the acute treatment of subjects with MDD as measured by Montgomery-Asberg Depression Rating Scale (MADRS) remission rates at Week 8.;Secondary Objective: 1. Conduct comparative analyses between treatment groups for MADRS, 17-item Hamilton Depression Rating Scale (HAMD17), Clinical Global Impression of Improvement (CGI-I), Clinical Global Impression of Severity (CGI-S), and Hamilton Anxiety Rating Scale (HAMA) 2. Characterize population pharmacokinetics in treatment groups 3. Evaluate effects on sexual functioning measured by Changes in Sexual Functioning Questionnaire (CSFQ) 4. Evaluate psychological health and functioning using Schwartz Outcomes Scale (SOS-10) 5. Evaluate safety and tolerability of SEC and sertraline monotherapy 6. Explore psychometric properties, including reliability, validity, and responsiveness of the Patient Global Impression - Dimensional (PGI-D) 7. haracterize the influence of the homozygous short/short (“SS”), long/long (“LL”), and heterozygous (“SL”) genotypes of the serotonin transporter gene promoter region on efficacy and safety variables in subjects with MDD ;Primary end point(s): Remission rate at Week 8, where remission is defined as a MADRS total score of =11. | — |
Countries
Estonia
Outcome results
None listed