Phase 3
Completed N=57
Lamotrigine for Symptoms of Geriatric Bipolar Depression
Bipolar Disorder · Depression, Bipolar
Source: ClinicalTrials.gov NCT00621842 ↗
Enrolled (actual)
57
Serious AEs
3.5%
Results posted
Oct 2011
Primary outcomePrimary: Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) — -15.5 units on a scale — p=<.01
Summary
This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) |
-15.5 | <.01 sig |
| SECONDARY Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) |
14; 12; 12; 11; 9; 9 | — |
| SECONDARY Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D) |
-15.2 | <.01 sig |
| SECONDARY Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS) |
-.47 | .49 |
| SECONDARY Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP |
-2.06 | <.01 sig |
| SECONDARY Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS) |
-.04 | .80 |
| SECONDARY Change in Body Weight From Baseline |
.83 | .36 |
| SECONDARY Number of Participants Who Fell at Least Once During the Study |
18 | — |
| SECONDARY Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS) |
-.79 | .08 |
| SECONDARY Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS) |
-.53 | .04 sig |
| SECONDARY Number of Participants Who Had a Fall That Required Medical Attention |
5 | — |
| SECONDARY Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine |
1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00621842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.