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This trial is complete. It is no longer accepting participants.

NCT00026052

NCT00026052
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You are between 18 and 70 years old (male or female)
  • If you are a woman who could become pregnant, you are using an accepted form of birth control
  • You are able to understand and agree to all the tests and procedures involved in the study
  • You are willing to read and sign a consent form after learning about the study
  • You have been diagnosed with recurring major depression without psychotic features, confirmed through a clinical interview
  • Your depression symptoms score at least 20 on a standard depression rating scale at two separate visits
  • Your depression symptoms did not improve by 20% or more during a washout period between the first two visits
  • In the doctor's opinion, you have had at least one previous episode of major depression (not counting your current one)
  • You have tried at least one standard antidepressant (such as an SSRI, bupropion, or venlafaxine) during a depressive episode
  • Your current depressive episode has lasted no longer than 24 months

Who may not be able to join:

  • You are currently experiencing psychotic symptoms (such as hallucinations or delusions)
  • You have taken part in another clinical drug trial within the past 30 days
  • You are currently pregnant or breastfeeding
  • You have a serious or unstable physical health condition affecting the liver, kidneys, stomach, lungs, heart, hormones, nervous system, immune system, or blood
  • You have an untreated thyroid condition (overactive or underactive)
  • You have abnormal liver enzyme levels in your blood, or a current or past blood disorder
  • You have a known allergy or bad reaction to the drug riluzole
  • You have had a substance abuse or dependence problem in the past 90 days
  • You have recently received a long-acting injectable antipsychotic medication (confirm with trial site)
  • You have taken certain specific medications too recently before the study, including some antidepressants or blood pressure drugs (confirm with trial site for exact timeframes)
  • You are currently taking other medications that affect the brain or nervous system, beyond what is allowed by the study
  • You have received clozapine (a specific medication) or electroconvulsive therapy (ECT) within the past 12 weeks
  • You have been diagnosed with schizophrenia or another psychotic disorder
  • You are considered by your doctor to be at serious risk of suicide, based on a specific rating scale score
  • You are currently receiving structured talk therapy (psychotherapy) or would need to during the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
National Institute of Mental Health (NIMH)
Registry
clinicaltrials_gov
Start date
1 November 2001

Where this trial is recruiting

🇺🇸 United States

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov