Cytokines, PUFA Tissue Concentrations and Treatment Selection in Antenatal MDD

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

For a number of reasons women with major depressive disorder often discontinue conventional antidepressants when they become pregnant and prefer not to take them when depressive illness develops in the course of pregnancy. There is now considerable evidence that the administration of the omega-3 polyunsaturated fatty acid, eicosapentaenoic acid (EPA), as monotherapy has antidepressant effects. If it could be clearly established as effective such an approach would offer a valuable alternative for woman who are at risk for, or who develop, depressive disorder during pregnancy. Strongly positive placebo-controlled trials of EPA supplementation, though, co-exist with entirely negative ones. No clear reasons for these discrepancies have emerged but one possibility is that the samples studied have differed in the proportion of individuals likely to benefit from EPA supplementation. As there has been no effort to identify such individuals we propose to explore two groups of measures, both relevant to EPA's likely mechanisms of action, as potential tools for identifying individuals likely to benefit this treatment. Hypothesis: Among women who experience major depressive episodes during their first two trimesters of pregnancy, baseline measures of cytokine activity and erythrocyte PUFA concentrations will be associated, in an additive or interactive fashion, with subsequent improvement in depressive symptoms among women taking omega-3 PUFA supplementation.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Coryell

Criteria

Inclusion Criteria:

1. women with uncomplicated pregnancies and within 24 weeks of their last menstrual period

2. describe symptoms over the previous two weeks sufficient to meet DSM IV criteria for MDD as determined by the SCID

3. have a 21-item HAM-D of 16 or more

Exclusion Criteria:

1. antidepressant use in preceding month

2. use in previous 2 wks of non-steroidal anti-inflammatory drugs (NSAIDS), antibiotics or glucocorticoids

3. use in previous 2 wks of psychotropic medications other than hypnotics or benzodiazepines in diazepam dose-equivalents greater than 2mg/day for insomnia

4. a previous diagnosis of an autoimmune disease, of hyperlipidemia, or of schizophrenia or schizoaffective disorder

5. evidence of substance dependence in previous 6 months

6. preoccupation with, or plans for, suicide

7. a history of hypersensitivity to fish or fish oil supplements

8. current use of anticoagulants

9. any current medical condition associated with clinically significant decreases in coagulability, i.e. systemic lupus erythematosis, VonWillebrend's disease

10. the initiation of regularly scheduled course of psychotherapy within the previous 2 months

11. current use of category D or category X medications