Phase 2
Completed N=234
Study Of 323U66 SR In Major Depressive Disorder
Source: ClinicalTrials.gov NCT00135512 ↗Enrolled (actual)
234
Serious AEs
6.0%
Results posted
Feb 2019
Primary outcomePrimary: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases — -16.8 Score on a scale
Summary
This study was designed to evaluate the efficacy and safety in major depressive disorder patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases |
-16.8 | — |
| SECONDARY Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases |
-24.6 | — |
| SECONDARY Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases |
-11.8; -17.3 | — |
| SECONDARY Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases |
68.7; 89.0 | — |
| SECONDARY Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases |
-1.3; -2.3 | — |
| SECONDARY Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases |
-5.0; -9.7 | — |
| SECONDARY Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases |
15.2; 26.7 | — |
Eligibility Criteria
Inclusion criteria
- Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
- Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
- Must have rating scores as outlined.
Exclusion criteria
- Current or past history of seizure disorder or brain injury.
- Current or past history of anorexia or bulimia nervosa.
- History of manic episode.
- Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.
- Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.
- Pregnant, possibly pregnant or lactating.
- Must not be suicidal.
- Blood pressure of SBP>160mmHg, DBP>100mmHg.
- History or complication of cancer or malignant tumour.
Data sourced from ClinicalTrials.gov (NCT00135512). 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.