Bipolar Depression
Conditions
Keywords
Bipolar, depression
Brief summary
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.
Detailed description
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.
Interventions
DRUGRiluzole
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
Sponsors
Mclean Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale | 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. |
| Young Mania Rating Scale | 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. |
| Clinical Global Impression Scale | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Riluzole Riluzole 100-200 mg/day | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Riluzole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Change in Hamilton Depression Rating Scale
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.
Time frame: Baseline (week 0) - week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Riluzole | Change in Hamilton Depression Rating Scale | -12.6 units on a scale |
p-value: <0.001Mixed Models Analysis
Secondary
Clinical Global Impression Scale
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).
Time frame: Baseline (week 0) - week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Riluzole | Clinical Global Impression Scale | -1.6 units on a scale |
p-value: <0.001Mixed Models Analysis
Secondary
Montgomery Asberg Depression Rating Scale
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.
Time frame: Baseline (week 0) - week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Riluzole | Montgomery Asberg Depression Rating Scale | -13.0 units on a scale |
p-value: <0.001Mixed Models Analysis
Secondary
Young Mania Rating Scale
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.
Time frame: Baseline (week 0) - week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Riluzole | Young Mania Rating Scale | -0.6 units on a scale |
p-value: 0.38Mixed Models Analysis