Phase 4
Completed N=26
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
Source: ClinicalTrials.gov NCT00419003 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression) — 24.4; 22.0 scores on a scale
◆ Published Evidence
Highly cited
599citations · ~35 / year
Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression.
Summary
This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.
Linked Publications (3)
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Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression.
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Riluzole for relapse prevention following intravenous ketamine in treatment-resistant depression: a pilot randomized, placebo-controlled continuation trial.
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Ketamine safety and tolerability in clinical trials for treatment-resistant depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression) |
24.4; 22.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients, 21- 70 years of age
- Subjects have a history of at least one previous episode of depression prior to the current episode (recurrent major depressive disorder) or have chronic major depressive disorder (at least two years' duration)
- Subjects have not responded to an adequate trial of one antidepressant in the current episode
Exclusion Criteria
- Female subjects who are either pregnant or nursing
- Serious, unstable illnesses
- Any previous use or treatment with ketamine, or riluzole
- Past intolerance to lamotrigine, including drug rash
Data sourced from ClinicalTrials.gov (NCT00419003) and the linked publication. 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.