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Completed

NCT Number: NCT00544544

Riluzole in the Treatment of Bipolar Depression

Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is associated with elevated brain glutamate activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate activity, will lead to clinical improvement in patients with bipolar depression.

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Key information

Conditions

Bipolar Depression Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

We hypothesize that riluzole will lead to significant reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in depressive symptoms will be associated with reduced glutamate levels in the anterior cingulate cortex, but not parieto-occipital cortex, both at day two and day 42.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female age 18-65
  • Meets DSM-IV criteria for Bipolar Disorder and is currently depressed
  • Current score of >/= 18 on the Hamilton Depression Scale

Exclusion criteria

  • Active psychotic/manic symptoms
  • Lifetime history of schizophrenia or obsessive compulsive disorder
  • Clinically significant medical disease
  • Women who are pregnant or lactating and women who are not using a medically accepted method of contraception.

Treatment and study plan

Riluzole

Drug

50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks

Other names: Rilutek

Primary outcomes

  1. Change in Hamilton Depression Rating Scale

    Time frame: Baseline (week 0) - week 6

    The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. Minimum score is zero and maximum score is 65. Higher scores indicate more severe depressive symptoms.

Secondary outcomes

  1. Montgomery Asberg Depression Rating Scale

    Time frame: Baseline (week 0) - week 6

    The Montgomery-Asberg Depression Rating Scale is a clinician-rated scale that measures the severity of depression symptoms. The 10 items measured are apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Minimum score is zero and maximum score is 60. Higher scores represent more severe depressive symptoms.

  2. Young Mania Rating Scale

    Time frame: Baseline (week 0) - week 6

    The Young Mania Rating Scale is a clinician-rated scale that measures the severity of mania symptoms. The 11 items measures are elevated mood, increased motor activity, sexual interest, sleep, irritability, speech, language-thought disorder, thought content, aggressive behavior, appearance, and insight. Minimum score is zero and maximum score is 60. Higher scores represent more severe mania symptoms.

  3. Clinical Global Impression Scale

    Time frame: Baseline (week 0) - week 6

    The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Official study title

Riluzole in the Treatment of Bipolar Depression: A Study of the Association Between Clinical Response and Change in Brain Glutamate Levels as Measured by Proton Magnetic Resonance Spectroscopy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 16, 2007
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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