Phase 2
Completed N=285
A Study of CX157 (TriRima) for the Treatment of Depression
Source: ClinicalTrials.gov NCT00739908 ↗Enrolled (actual)
285
Serious AEs
2.1%
Results posted
Jun 2012
Primary outcomePrimary: Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS) — -12.5; -12.3 units on a scale
Summary
The purpose of this study is to examine the efficacy of CX157 60 mg administered three times a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS) |
-12.5; -12.3 | — |
| SECONDARY Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate |
31.7; 34.3 | — |
| SECONDARY Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate |
19.4; 23.1 | — |
| SECONDARY The Hospital Anxiety and Depression Scale (HADS) |
-8.7; -8.9 | — |
| SECONDARY Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items) |
-22.58; -23.39 | — |
| SECONDARY Clinical Global Impression - Improvement of Illness (CGI-I) |
36.7; 39.9 | — |
| SECONDARY Clinical Global Impression - Severity of Illness (CGI-S) |
36.7; 39.9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female = 18 years of age and 40 on the IDS-SR30 assessed via IVRS at Screening and Randomization
Exclusion Criteria
- Subject's current MDD episode is >2 years
- History of Substance Use Disorder at Screening or 12 months prior (except for nicotine)
- Current diagnosis of Obsessive-Compulsive Disorder;
- Panic Disorder or Post-Traumatic Stress Disorder;
- Anorexia nervosa, Bulimia nervosa, or eating disorder not otherwise specified;
- Any Axis I Disorder clinically predominant to their MDD (within 6 mo);
- Presence of psychotic features with current depressive episode;
- Antisocial or Borderline Personality Disorder
- At risk for suicide
- Lack of response to >2 trials of adequate dose & duration of antidepressants of different mechanistic classes
- Electroconvulsive therapy within 1 year of Screening
- Subject has taken any psychoactive drug within 2 weeks of Randomization
- History of cardiac abnormalities including abnormal vital sign measurements
- Clinically significant abnormal ECG at Screening
- History within past 2 years of: Significant head trauma;
- Surgical procedure involving brain or meninges; Encephalitis or meningitis;
- Degenerative CNS disorder (Alzheimer's or Parkinson's);
- Epilepsy;
- Mental retardation
- Clinically significant Liver Function Test (LFT) and other lab abnormalities
- A history of hypothyroidism and treatment with a stable dosage of thyroid replacement medication for 2 yrs may not preclude participation if the malignancy was local and without metastasis or recurrence and, if treated with chemotherapy, had no nervous system complications (e.g basal cell carcinoma);
- Pheochromocytoma
- Positive urine test for drugs of abuse (blood for alcohol)
- Female subject who is pregnant or lactating
- Poor likelihood of subject's cooperation or compliance
Data sourced from ClinicalTrials.gov (NCT00739908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.