Bipolar 1 Disorder
Conditions
Keywords
Bipolar, Mania, Acute, In-patient, Manic State, Manic Episode, Mixed Features, Episode with Mixed Features, Mixed Mania, Bipolar Episode
Brief summary
This is a clinical research study for an investigational drug called RAP-219 in participants with bipolar I disorder. This study is being conducted to determine if RAP-219 is safe and effective in participants experiencing mania associated with bipolar I disorder.
Detailed description
This is a Phase 2, proof-of-concept, multi-center, randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of RAP-219 in adult participants experiencing mania associated with bipolar I disorder. This is a 3-week inpatient clinical trial.
Interventions
DRUGRAP-219
RAP-219 tablets administered orally, once daily for 21 days
OTHERPlacebo
Matching placebo tablets administered orally, once daily for 21 days
Sponsors
Rapport Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a placebo-controlled trial of active drug versus placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of bipolar I disorder, with or without psychotic symptoms, as confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT). Episode may contain mixed features, as confirmed by Montgomery-Åsberg Depression Rating Scale (MADRS). * Had at least one prior documented manic episode (with or without psychotic symptoms) that required treatment, within 5 years prior to Visit 1
Exclusion criteria
* History of any of the following diagnoses: a. schizophrenia; schizoaffective disorder; major depressive disorder; moderate or severe substance or alcohol use disorder; as assessed by the SCID-5-CT b. delirium, dementia, amnestic, or other cognitive disorders; borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorders; by medical history and/or Investigator opinion Note: Any other current diagnoses must be discussed with the Medical Monitor. * Rapid cycler, defined as experiencing ≥4 distinct mood episodes (ie, manic or depressive) each meeting full DSM-5 criteria in the previous 12 months, and each separated by ≥2 months of full or partial remission, or a switch to an episode of the opposite polarity, as assessed by the SCID-5-CT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Young Mania Rating Scale (YMRS) | Baseline to End of Treatment at Week 3 | The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Bipolar Version (CGI-BP) Severity of Illness Mania score | Baseline to end of Treatment at Week 3 | The CGI-BP Severity of Illness Mania score is a clinician-rated scale used to assess the severity of manic symptoms, depression and overall illness severity in individuals with bipolar disorder. The mania score ranges from 1 (not ill) to 7 (very severely ill), with higher scores indicating greater severity of manic symptoms. |
| Treatment Emergent Adverse Events (TEAEs) | Baseline to end of Study Period 8 Weeks after date of last dose | Incidence and severity of treatment-emergent adverse events (TEAEs). |
| Heart Rate | Baseline to end of Study Period 8 Weeks after date of last dose | Change in Heart Rate (BPM) |
| Respiratory Rate | Baseline to end of Study Period 8 Weeks after date of last dose | Change in Respiratory Rate (breaths per minute) |
| Body Temperature | Baseline to end of Study Period 8 Weeks after date of last dose | Change in body temperature |
| Blood Pressure | Baseline to end of Study Period 8 Weeks after date of last dose | Change in blood pressure (Hg mm) |
| Laboratory Analytes | Baseline to end of Study Period 8 Weeks after date of last dose | Change in laboratory analytes (absolute value) |
| Electrocardiogram (ECG) QTc interval | Baseline to end of Study Period 8 Weeks after date of last dose | Changes in electrocardiogram (ECGs); QTc prolongation |
| Electrocardiogram (ECG) abnormal findings | Baseline to end of Study Period 8 Weeks after date of last dose | Shift table of normal to abnormal ECG findings |
| Suicidality | Baseline to end of Study Period 8 Weeks after date of last dose | Incidence of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREdwin A Gomez, MD
CenExel Research Centers of America
Outcome results
None listed