Table 1.
Comparison of demographic and clinical characteristics at baseline
| Sham | Active | |
|---|---|---|
| n | 34 | 32 |
| Medications (yes/no) | ||
| Any concurrent medication | 27/7 | 22/10 |
| Antidepressant | 23/11 | 20/12 |
| Lithium | 1/33 | 2/30 |
| Benzodiazepinea | 2/32 | 2/30 |
| Antipsychotic | 6/28 | 4/28 |
| Anticonvulsant | 5/29 | 1/31 |
| Clinical and demographic variables (mean, SD) | ||
| Gender (m/f) | 19/15 | 17/15 |
| Melancholic (yes/no) | 19/9 | 12/12 |
| MDD/BP1/BP2 | 30/3/1 | 30/0/2 |
| Age (years) | 48.8 (12.3) | 47.5 (12.0) |
| Age at onset (years) | 27.0 (9.6) | 27.5 (9.6) |
| Duration of current episode (months) | 24.4 (32.2) | 37.2 (48.0) |
| Duration of previous episodes (months) | 65.9 (65.8) | 88.5 (93.6) |
| Antidepressants failed current episode | 2.1 (1.7) | 2.6 (2.9) |
| Total lifetime failed antidepressants | 4.0 (3.0) | 5.0 (5.1) |
| Maudsley staging score | 7.3 (2.1) | 6.5 (1.9) |
| Baseline MADRS score | 29.5 (4.6) | 30.1 (5.0) |
| Baseline BDI-II score | 33.8 (9.1) | 34.1 (9.4) |
| Baseline CGI-S score | 4.4 (0.6) | 4.4 (0.6) |
| Baseline Q-LES-SF score | 32.8 (10.5) | 34.9 (11.2) |
| Baseline TEQ score | 24.5 (7.6) | 24.1 (7.1) |
Abbreviations: BP1/BP2, bipolar I and bipolar II disorder; BDI-II, Beck Depression Inventory; CGI-S, Clinician Global Impression Severity scale, a 7-point clinician-rated scale ranked from 1-normal to 7-extremely ill; MADRS, Montgomery-Asberg Depression Rating Scale; MDD, major depressive disorder; Q-LES-SF, Quality of Life Enjoyment and Satisfaction Questionnaire—Short Form; TEQ, Treatment Expectancy Questionnaire.
aParticipants were required to cease benzodiazepine medication use prior to commencing the trial.