Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder, Bipolar Depression

In brief

Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in treating bipolar depression when taken with a mood stabilizer medicine. The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the treatment of major depression, but is not FDA approved for the treatment of bipolar depression. It is, however, standard practice for many doctors is to use antidepressants, like Celexa, to treat their patients with bipolar disorder depression. The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at the possibility that there may be a gene that could predict if a person would get better taking the drug using genetics.

Key facts

Study ID

NCT00562861

Run by

Tufts Medical Center

People needed

119

Starts

2007-11-01

Expected to finish

2014-07-01

Last updated by the study team

2017-03-24

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current age ≥18 years
• DSM-IV diagnosis of BPD, type-I, or type-II
• Current major depressive episode using DSM-IV criteria, lasting 8 weeks or longer.
• Use of lithium, divalproex, carbamazepine, or lamotrigine at therapeutic serum levels or doses for ≥4 weeks prior to study entry, or willingness to accept one of these agents.
• Prior to initial evaluations, each subject must provide competent, written, informed consent.

You may not qualify if…

• Past non-response to a therapeutic trial of R,S-citalopram (≥100 mg/day for ≥8 weeks).
• Previous intolerance of R,S-citalopram;
• Diagnosis of unipolar depression
• Diagnosis of schizoaffective disorder
• Serious medical illness with acute instability (cardiac, respiratory, hepatic, renal), based on hospitalization in the past month
• Abnormal thyroid function tests
• Previous allergic reaction to or inability to tolerate lithium, divalproex, or carbamazepine at therapeutic serum levels.
• Current or past renal dysfunction if taking lithium
• Current or past hepatitis or other liver disease if taking divalproex
• Current or past hematologic disease if on carbamazepine
• Severe suicidal ideation, plan or intent, as documented by a score of ≥4 on the Montgomery Åsberg Depression Rating Scale suicidality item (Item 10).
• Presence of psychosis
• Cognitive impairment sufficient to impair ability to give informed consent.
• Current pregnancy, or inability to utilize contraception
• The presence of any metallic implants
• History of claustrophobia

Where it is running

• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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