Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

NCT00562861 | Completed Phase 2 Results DMC

• 2 other identifiers: MH78060-01A15R01MH078060-04
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Bipolar Depression

Keywords

Bipolar Disorder; Bipolar Depression; Clinical Trials, Phase II; Clinical Pharmacology

Outcome Measures

Primary Outcomes (1)

• MADRS Rating Scale Change

  Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.

  6 weeks

Study Arms (2)

citalopram + mood stabilizer

ACTIVE COMPARATOR

All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to citalopram.

Drug: citalopram + mood stabilizer

placebo + mood stabilizer

PLACEBO COMPARATOR

All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to placebo

Drug: placebo + mood stabilizer

Interventions

citalopram + mood stabilizer DRUG

Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d. No target dose will be provided but rather clinicians will dose to clinical efficacy. Thus the study will provide clinicians data on the effective dose if it is positive. The dose will not be predetermined at static amounts.

Also known as: Celexa

citalopram + mood stabilizer

placebo + mood stabilizer DRUG

This arm will only receive mood stabilizing medication. All subjects will be required to receive treatment with lithium, lamotrigine, valproate, or carbamazepine for at least one month at therapeutic blood levels or doses before randomization, or they must initiate one of these agents at study entry.

Also known as: lithium, lamotrigine, valproate, or carbamazepine

placebo + mood stabilizer

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Ghaemi SN, Whitham EA, Vohringer PA, Barroilhet SA, Amerio A, Sverdlov O, Patkar AA. Citalopram for Acute and Preventive Efficacy in Bipolar Depression (CAPE-BD): A Randomized, Double-Blind, Placebo-Controlled Trial. J Clin Psychiatry. 2021 Jan 12;82(1):19m13136. doi: 10.4088/JCP.19m13136.

  PMID: 33434956 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Citalopram; Lithium; Lamotrigine; Valproic Acid; Carbamazepine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Triazines; Heterocyclic Compounds, 1-Ring; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids; Dibenzazepines; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Nassir Ghaemi
• Organization: Tufts Medical Center

nghaemi@tuftsmedicalcenter.org

6176365735

Study Officials

• Nassir Ghaemi, MD, MPH

  Tufts University Medical

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 22, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 24, 2017
• Results First Posted: February 13, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)