Bipolar Disorder: Novel Clinical Trials I

To finish out the bipolar disorder topic month I will review some of the novel clinical trials in this condition.

Clinicaltrials.gov is a valuable resource in searching for active and recently completed clinical trials.

Here are some of the rostered trials from this site related to bipolar disorder that caught my attention.

Sensoril for Bipolar Disorder
Sensoril is the trade name for the natural product ashwagandha an herbal extract from the herb Withania somnifera. This trial was sponsored through the University of Pittsburgh. It has been completed and the results were published in 2013. The study targeted some of the cognitive impairment associated with bipolar disorder. The results pointed to some evidence for improvement in working memory, reaction time and social cognition with the drug.

Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
This trial sponsored by Massachusetts General Hospital is listed as currently recruiting subjects. The study compares a form of mindfulness therapy compared to brief supportive therapy on total sleep time in a group of subjects with bipolar disorder and sleep complaints. Sleep problems including both insomnia and hypersomnia are common in bipolar and new innovative interventions are needed.

N-Acetyl Cysteine and Aspirin as Adjunctive Treatment for Bipolar Disorder
This trial is sponsored by the University of Texas Health Science Center, Houston and is also listed as currently recruiting subjects. Subjects receive aspirin, n-acetyl-cysteine or both in addition to their usual bipolar disorder drug treatment regimen. The study seeks to see if an anti-inflammatory drug or an antioxidant drug can reduce depression symptoms. 

Minocycline and Aspirin in the Treatment of Bipolar Depression
This study is sponsored by the Laureate Institute of Brain Research in Tulsa in collaboration with the Stanley Medical Research Institue and the University of Oklahoma.  Subjects are eligible for enrollment if they have bipolar disorder and are currently depressed. Subjects receive aspirin, minocycline or a combination compared to placebo and are monitored for change in depression scores as measured by the Montgomery-Asberg Depression Rating. Disclosure: I am a participating research psychiatrist in this protocol. 

Readers with more interest in these trials can find more information by going to clinicaltrials.gov and typing in bipolar disorder in the search box. Additionally, specific trial information can be access by clicking on the link in the headings for this post.

I have listed some of the relevant citations related to these trials below.

In the next post I will look at four more novel trials in bipolar disorder.

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Chengappa KN, Bowie CR, Schlicht PJ, Fleet D, Brar JS, & Jindal R (2013). Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. The Journal of clinical psychiatry, 74 (11), 1076-83 PMID: 24330893

Deckersbach T, Hölzel BK, Eisner LR, Stange JP, Peckham AD, Dougherty DD, Rauch SL, Lazar S, & Nierenberg AA (2012). Mindfulness-based cognitive therapy for nonremitted patients with bipolar disorder. CNS neuroscience & therapeutics, 18 (2), 133-41 PMID: 22070469

Savitz J, Preskorn S, Teague TK, Drevets D, Yates W, & Drevets W (2012). Minocycline and aspirin in the treatment of bipolar depression: a protocol for a proof-of-concept, randomised, double-blind, placebo-controlled, 2x2 clinical trial. BMJ open, 2 (1) PMID: 22357572