Phase 2
Completed N=68
A Study of Ketamine in Patients With Treatment-resistant Depression
Source: ClinicalTrials.gov NCT01627782 ↗Enrolled (actual)
68
Serious AEs
3.0%
Results posted
Aug 2016
Primary outcomePrimary: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15 — 35.6; 33.3; 36.8; 35.4 Units on a scale — p=< 0.001
Summary
The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15 |
35.6; 33.3; 36.8; 35.4; -5.7; -18.4 | < 0.001 sig |
| SECONDARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29 |
35.6; 33.3; 36.8; 35.4; -23.5; -27.1 | — |
| SECONDARY Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
2; 11; 1; 7; 1; 13 | — |
| SECONDARY Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
1; 6; 0; 3; 1; 12 | — |
| SECONDARY Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
1; 7; 0; 4 | — |
| SECONDARY Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29) |
5.0; 5.0; 5.0; 5.0; 0.0; -2.0 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase |
4.0; 2.0; 4.0; 2.0 | — |
| SECONDARY Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29) |
8.0; 7.5; 8.0; 7.0; 0.0; -4.0 | — |
| SECONDARY Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase |
4.0; 2.0; 4.0; 3.0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Ketamine |
207; 168; 219; 189 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine |
0.67; 0.66; 0.67; 0.67 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last]) |
312; 295; 342; 293 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) |
369; 344; 416; 340 | — |
| SECONDARY Total Systemic Clearance (CL) of Ketamine |
113; 108; 93.9; 117 | — |
| SECONDARY Volume of Distribution at Steady-State (Vss) of Ketamine |
275; 276; 239; 290 | — |
| SECONDARY Elimination Half-Life (t1/2) |
2.18; 2.18; 2.39; 2.21 | — |
Eligibility Criteria
Inclusion Criteria
- Be medically stable on the basis of clinical laboratory tests performed at screening
- Meet diagnostic criteria for recurrent major depressive disorder (MDD), without psychotic features
- Have a history of inadequate response, ie treatment was not successful, to at least 1 antidepressant
- Have an Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) total score >= 40 at screening and predose at Day 1
- Inpatient or agreed to be admitted to the clinic on each dosing day
Exclusion Criteria
- Has uncontrolled hypertension
- Has a history of, or current signs and symptoms of diseases, infections or conditions that in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments
- Has known allergies, hypersensitivity, or intolerance to ketamine or its excipients
- Is unable to read and understand the consent forms and patient reported outcomes, complete study-related procedures, and/or communicate with the study staff
Data sourced from ClinicalTrials.gov (NCT01627782). 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.