Lamotrigine for Symptoms of Geriatric Bipolar Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00621842
• Date of registration: 12/02/2008
• Primary sponsor: University Hospitals of Cleveland
• Public title: Lamotrigine for Symptoms of Geriatric Bipolar Depression Geri-BD SAD
• Scientific title: Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression
• Date of first enrolment: January 2008
• Target sample size: 57
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00621842
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Martha Sajatovic, MD
• Affiliation: Case Western Reserve University School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 60 Years or older

- BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P)

- HAM-D score > 18 (GRID-HAM-D 24-item version)

- Availability of an Informant is encouraged but not required for study participation

Exclusion Criteria:

- Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional
disorder

- Contraindication to lamotrigine (Physician interview, medical assessment)

- Documented history of intolerance to lamotrigine

- Patients who have previously failed to respond to at least 12 weeks of treatment with
lamotrigine

- Active substance dependence (SCID-I/P) or substance-related safety issues or PI
concerns

- Mood Disorder Due to a General Medical Condition or Treatment (Physician interview)

- Rapid cycling (Physician interview): As defined in DSM-IV: At least 4 episodes of
mood disturbance in the previous 12 months that meet criteria for a Major Depressive,
Manic, Mixed or Hypomanic Episode. Episodes are distinguished either by partial or
full remission for at least 2 months or by a switch to an episode of opposite
polarity

- Dementia (by DSM-IV or brain degenerative diseases; Physician interview);

- Inability to communicate in English (i.e., interview cannot be conducted without an
interpreter; subject largely unable to understand questions and cannot respond in
English)

- Clinically significant sensory impairment (i.e., cannot see well enough to read
consent or visually-presented material; cannot hear well enough to cooperate with
interview; Physician interview)

- Recent history of cardiovascular, peripheral vascular events or stroke

- High risk for suicide (e.g., active SI or current intent or plan)

- Inpatient status



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bipolar Disorder

Depression, Bipolar

Intervention(s)

Drug: Lamotrigine novel formulation

Drug: Lamotrigine regular tablet formulation

Primary Outcome(s)

Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) [Time Frame: 12 weeks]

Secondary Outcome(s)

Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) [Time Frame: 12 weeks]

Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP [Time Frame: 12 weeks]

Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS) [Time Frame: 12 weeks]

Change in Body Weight From Baseline [Time Frame: 12 weeks]

Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D) [Time Frame: 12 weeks]

Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS) [Time Frame: 12 weeks]

Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS) [Time Frame: 12 weeks]

Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS) [Time Frame: 12 weeks]

Number of Participants Who Fell at Least Once During the Study [Time Frame: 12 weeks]

Number of Participants Who Had a Fall That Required Medical Attention [Time Frame: 12 weeks]

Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine [Time Frame: 12 weeks]

Secondary ID(s)

GSK110720

IND 78,081

L0971

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline