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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00621842

NCT00621842
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You are 60 years of age or older
  • You have been diagnosed with Bipolar Disorder (Type I or Type II) and are currently experiencing a depressive episode
  • You have scored above 18 on a standard depression rating scale, indicating a significant level of depression symptoms
  • Having a close friend or family member who can provide information about you is helpful but not required

Who may not be able to join:

  • You have a long-term psychotic condition such as schizophrenia, schizoaffective disorder, or delusional disorder
  • You have a medical reason why you cannot take the medication lamotrigine (confirm with trial site)
  • You have a documented history of not tolerating lamotrigine well
  • You have previously tried lamotrigine for at least 12 weeks and it did not help you
  • You are currently dependent on alcohol or drugs, or there are safety concerns related to substance use
  • Your mood disorder is believed to be caused by another medical condition or a medical treatment
  • You experience "rapid cycling," meaning you have had 4 or more mood episodes (depression, mania, or mixed states) within the past 12 months
  • You have been diagnosed with dementia or a degenerative brain disease
  • You are unable to communicate in English without the help of an interpreter
  • You have significant vision or hearing problems that would prevent you from taking part in interviews or reading study materials
  • You have a recent history of heart disease, blood vessel problems, or stroke
  • You are considered at high risk for suicide, for example if you are having active thoughts of or plans to end your life
  • You are currently admitted as an inpatient in a hospital or medical facility

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
University Hospitals Cleveland Medical Center
Registry
clinicaltrials_gov
Start date
1 January 2008
Est. completion
1 March 2010

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov