Phase 2
Completed N=469
A Study for Participants With Major Depression
Source: ClinicalTrials.gov NCT00420004 ↗Enrolled (actual)
469
Serious AEs
0.6%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline to Week 8 in the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score — -13.2; -12.6; -14.7 units on a scale — p=0.494
Summary
This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in treating adults with major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 8 in the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score |
-13.2; -12.6; -14.7 | 0.494 |
| SECONDARY Change From Baseline to Week 8 in Maier-Philipp Subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17) |
-6.7; -6.2; -7.6 | — |
| SECONDARY Response and Remission Rates |
54.0; 48.4; 53.7; 38.7; 31.1; 42.6 | — |
| SECONDARY Clinical Global Impression of Improvement Score at Week 8 |
2.2; 2.3; 2.0 | — |
| SECONDARY Change From Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score up to Week 8 Endpoint |
-9.7; -9.6; -11.6 | — |
| SECONDARY Change From Baseline on the 36-item Short-Form (SF-36) Health Status Survey Mental and Physical Components up to Week 8 Endpoint |
13.4; 12.6; 12.4; 4.17; 2.37; 2.74 | — |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptomatology Total Score up to Week 8 Endpoint |
-10.2; -8.3; -11.6 | — |
| SECONDARY Change From Baseline in Beck Scale for Suicide Ideation up to Week 8 Endpoint |
-0.90; -0.54; -0.78 | — |
| SECONDARY Change From Baseline in Modified Overt Aggression (OAS-M) Scale up to Week 8 Endpoint |
-4.1; -4.2; -3.9; -1.0; -0.9; -1.0 | — |
| SECONDARY Change From Baseline in Arizona Sexual Experiences Scale up to Week 8 Endpoint |
-2.68; -1.69; -1.65 | — |
| SECONDARY Change From Baseline in Insomnia Severity Index up to Week 8 Endpoint |
-7.53; -7.44; -8.02 | — |
| SECONDARY Change From Baseline to Week 8 in Fatigue Severity Scale |
-2.0; -1.8; -2.2 | — |
| SECONDARY Pharmacokinetics: Predicted Maximal Concentration of LY2216684 at Steady State (Cmax,ss) at Week 8 Endpoint |
10.5; 22.6; 32; 40.6 | — |
| SECONDARY Number of Participants With at Least 1 Serious Adverse Event (Safety and Tolerability) |
2; 1; 2 | — |
| SECONDARY Change From Baseline to Week 8 in the 21-item Hamilton Depression Rating Scale (HAM-21) Total Score |
-13.6; -13.0; -15.0 | — |
| SECONDARY Cognitive Assessment Battery: Change From Baseline in Word List Learning and Delayed Recall Test (WLDRT) up to Week 8 Endpoint |
0.5; 0.3; 0.3; 0.4; 0.2; 0.0 | — |
| SECONDARY Cognitive Assessment Battery: Change From Baseline in Symbol Digit Substitution Test (SDST) up to Week 8 Endpoint |
3.2; 2.5; 2.2 | — |
| SECONDARY Cognitive Assessment Battery: Change From Baseline in Two Digit Cancellation Test up to Week 8 Endpoint |
0.8; 1.2; 1.0 | — |
| SECONDARY Cognitive Assessment Battery: Change From Baseline in Trail Making A up to Week 8 Endpoint |
-9.9; -11.1; -5.6 | — |
Eligibility Criteria
Inclusion Criteria
- Meet criteria for major depressive disorder (MDD) without psychotic features.
- Have education level and a degree of understanding such that the participant can communicate with the site study personnel.
- Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol.
Exclusion Criteria
- Have had any additional, ongoing psychiatric condition other than major depression or dysthymia that was considered the primary diagnosis within 6 months of the first study visit.
- Have a lifetime history of Bipolar I or II Disorder, psychotic disorder, or a factitious disorder.
- Are judged to be at high risk for imminently harming themselves or others.
- Have a serious medical illness, including any cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic disease, or clinically significant laboratory or electrocardiogram (ECG) abnormality. Clinically significant lab abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require intervention.
- Have any diagnosed medical condition which could be exacerbated by treatment with LY2216684, including hypertension, increased heart rate, arrhythmias, heart disease, narrow angle glaucoma, or urinary hesitancy.
Data sourced from ClinicalTrials.gov (NCT00420004). 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.