Table 1.

Phases and Timing of Protocol Events

Phase	Months in study	Time	Week	Event
Diagnostic Evaluation	0	T1	−1	Triage Evaluation; Psychiatric Evaluation; medical screen and drug wash-out; Informed Consent; 1st Psychoeducational Session
Acute Phase-Cognitive Therapy (approx. 12–14 weeks)
					Sessions
			1		1–2
			2		3–4
			3		5–6
	1		4		7–8
				HRSD-17 reduction from baseline
				≥40%(early responders)	<40%(late responders)	HRSDs collected for Risk Assessment
			5	9	9–10		2nd Psycho-educational Session at about Session 11
			6	10	11–12
			7	11	13–14	1
	2		8	12	15–16	2
			9	13	17	3
			10	14	18	4
			11	15	19	5
	3+*		12–14	16	20	6
Blinded Evaluation** Randomization	4	T2	13–16			7
Continuation Phase (8 months)	Months in study	Time	Months Post Acute		Higher Risk		Lower Risk
					Continuation Sessions C-CT, FLX, PBO		Blinded Evaluations
	5		1		1–2
	6		2		3–4
	7		3		5
Blinded Evaluation**	8	T3	4		6, T3		T3
	9		5		7
	10		6		8
	11		7		9
Blinded Evaluation**	12	T4	8		10, T4		T4
Follow-Up (24 months)	Months in study	Time	Months Post Acute	Months Post Continuation	Higher Risk		Lower Risk
	13		9		Clinic Follow-up 1
	14		10		Clinic Follow-up 2
	15		11
Blinded Evaluation	16	T5	12	4	T5		T5
	17		13
	18		14
	19		15
Blinded Evaluation	20	T6	16	8	T6		T6
	21		17
	22		18
	23		19
Blinded Evaluation	24	T7	20	12	T7		T7
	25		21
	26		22
	27		23
Blinded Evaluation	28	T8	24	16	T8		T8
	29		25
	30		26
	31		27
Blinded Evaluation	32	T9	28	20	T9		T9
	33		29
	34		30
	35		31
Blinded Evaluation	36	T10	32	24	T10		T10

^*Allows for rescheduled sessions up to Week 14;

^**Blinded Evaluations occur at the end of the week/month;

T = Time