Pharmacotherapy augmentation strategies in treatment‐resistant anxiety disorders

Jonathan C Ipser; Paul Carey; Yumna Dhansay; Nuraan Fakier; Soraya Seedat; Dan J Stein

doi:10.1002/14651858.CD005473.pub2

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Figure 1

Pub Bias ‐ Response.

Evidence of small sample effect on the CGI‐I

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Figure 2

Pub Bias ‐ Symptoms.

Evidence of small sample effect on measures of symptom severity

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Figure 3

Egger plot (CGI‐I).

Regression of standardised treatment estimate for treatment response on measure of precision

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Figure 4

Egger plot (SMD).

Regression of standardised treatment estimate for continuous outcomes on measure of precision

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Analysis 1.1

Comparison 1 Medication vs Placebo: Primary outcomes, Outcome 1 Clinical Global Impression (CGI‐I) scale response ‐ anxiety disorders.

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Analysis 1.2

Comparison 1 Medication vs Placebo: Primary outcomes, Outcome 2 Clinical Global Impressions (CGI‐I) scale response ‐ augmentation agents.

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Analysis 1.3

Comparison 1 Medication vs Placebo: Primary outcomes, Outcome 3 Clinical Global Impressions (CGI‐I) scale response ‐ antipsychotics.

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Analysis 1.4

Comparison 1 Medication vs Placebo: Primary outcomes, Outcome 4 Symptom severity scale ‐ anxiety disorders.

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Analysis 1.5

Comparison 1 Medication vs Placebo: Primary outcomes, Outcome 5 Symptom severity scale ‐ augmentation agents.

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Analysis 1.6

Comparison 1 Medication vs Placebo: Primary outcomes, Outcome 6 Symptom severity scale ‐ antipsychotics.

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Analysis 2.1

Comparison 2 Medication vs Placebo: Comorbid symptoms, Outcome 1 Depression scale (typically Hamilton Depression Scale) ‐ Anxiety disorders.

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Analysis 2.2

Comparison 2 Medication vs Placebo: Comorbid symptoms, Outcome 2 Depression scale (typically Hamilton Depression Scale) ‐ Augmentation agents.

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Analysis 2.3

Comparison 2 Medication vs Placebo: Comorbid symptoms, Outcome 3 Hamilton Anxiety Rating Scale (HAM‐A) ‐ Anxiety disorders.

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Analysis 2.4

Comparison 2 Medication vs Placebo: Comorbid symptoms, Outcome 4 Hamilton Anxiety Rating Scale (HAM‐A) ‐ Augmentation agents.

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Analysis 3.1

Comparison 3 Medication vs Placebo: Quality of Life Scales, Outcome 1 Sheehan Disability Scale.

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Analysis 4.1

Comparison 4 Medication vs Placebo: Drop‐out Rate, Outcome 1 Drop‐out rate due to treatment emergent adverse effects.

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Analysis 5.5

Comparison 5 Subgroup analyses ‐ Methodological criteria, Outcome 5 Industry versus non‐industry funded trials.

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Analysis 5.7

Comparison 5 Subgroup analyses ‐ Methodological criteria, Outcome 7 Industry versus non‐industry funded trials.

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Analysis 6.1

Comparison 6 Subgroup analyses ‐ Clinical criteria, Outcome 1 Inclusion of major depression vs. non‐inclusion: CGI‐I.

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Analysis 6.2

Comparison 6 Subgroup analyses ‐ Clinical criteria, Outcome 2 Inclusion of major depression vs. non‐inclusion.

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Analysis 6.3

Comparison 6 Subgroup analyses ‐ Clinical criteria, Outcome 3 Adequate previous trials versus inadequate trials: CGI‐I.

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Analysis 6.4

Comparison 6 Subgroup analyses ‐ Clinical criteria, Outcome 4 Adequate previous trials versus inadequate trials.

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Analysis 6.5

Comparison 6 Subgroup analyses ‐ Clinical criteria, Outcome 5 Non‐responders versus partial responders: CGI‐I.

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Analysis 6.6

Comparison 6 Subgroup analyses ‐ Clinical criteria, Outcome 6 Non‐responders versus partial responders.

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Comparison 1. Medication vs Placebo: Primary outcomes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Clinical Global Impression (CGI‐I) scale response ‐ anxiety disorders Show forest plot	9	250	Risk Ratio (M‐H, Random, 95% CI)	3.16 [1.08, 9.23]

1.2 Obsessive compulsive disorder (OCD)	9	250	Risk Ratio (M‐H, Random, 95% CI)	3.16 [1.08, 9.23]
2 Clinical Global Impressions (CGI‐I) scale response ‐ augmentation agents Show forest plot	9	250	Risk Ratio (M‐H, Random, 95% CI)	3.16 [1.08, 9.23]

2.1 antipsychotics	6	187	Risk Ratio (M‐H, Random, 95% CI)	3.55 [0.99, 12.72]
2.4 Other medications	3	63	Risk Ratio (M‐H, Random, 95% CI)	2.27 [0.22, 23.37]
3 Clinical Global Impressions (CGI‐I) scale response ‐ antipsychotics Show forest plot	6	187	Risk Ratio (M‐H, Random, 95% CI)	3.55 [0.99, 12.72]

3.1 haloperidol	1	34	Risk Ratio (M‐H, Random, 95% CI)	15.0 [0.92, 243.52]
3.2 quetiapine	2	81	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.30, 8.45]
3.3 risperidone	3	72	Risk Ratio (M‐H, Random, 95% CI)	5.66 [1.40, 22.84]
4 Symptom severity scale ‐ anxiety disorders Show forest plot	14	337	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.67 [‐0.90, ‐0.43]

4.1 Generalized anxiety disorder (GAD)	1	21	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.98 [‐1.90, ‐0.05]
4.2 Obsessive compulsive disorder	12	291	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.55 [‐0.79, ‐0.30]
4.3 Panic DIsorder	1	25	Std. Mean Difference (IV, Fixed, 95% CI)	‐3.73 [‐5.10, ‐2.36]
5 Symptom severity scale ‐ augmentation agents Show forest plot	14	337	Std. Mean Difference (IV, Random, 95% CI)	‐0.87 [‐1.37, ‐0.36]

5.1 antipsychotics	8	219	Std. Mean Difference (IV, Random, 95% CI)	‐0.71 [‐1.11, ‐0.32]
5.2 beta‐blockers	2	39	Std. Mean Difference (IV, Random, 95% CI)	‐2.95 [‐4.49, ‐1.40]
5.4 Other medications	4	79	Std. Mean Difference (IV, Random, 95% CI)	‐0.33 [‐1.43, 0.77]
6 Symptom severity scale ‐ antipsychotics Show forest plot	8	219	Std. Mean Difference (IV, Random, 95% CI)	‐0.71 [‐1.11, ‐0.32]

6.1 olanzapine	1	21	Std. Mean Difference (IV, Random, 95% CI)	‐0.98 [‐1.90, ‐0.05]
6.2 quetiapine	4	129	Std. Mean Difference (IV, Random, 95% CI)	‐0.77 [‐1.52, ‐0.02]
6.3 risperidone	3	69	Std. Mean Difference (IV, Random, 95% CI)	‐0.63 [‐1.12, ‐0.14]

Comparison 1. Medication vs Placebo: Primary outcomes

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Comparison 2. Medication vs Placebo: Comorbid symptoms

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Depression scale (typically Hamilton Depression Scale) ‐ Anxiety disorders Show forest plot	13	310	Std. Mean Difference (IV, Random, 95% CI)	‐0.23 [‐0.70, 0.23]

1.1 Generalized anxiety disorder (GAD)	1	21	Std. Mean Difference (IV, Random, 95% CI)	‐0.91 [‐1.83, 0.01]
1.2 Obsessive compulsive disorder	11	264	Std. Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.49, 0.41]
1.3 Panic Disorder	1	25	Std. Mean Difference (IV, Random, 95% CI)	‐1.87 [‐2.83, ‐0.90]
2 Depression scale (typically Hamilton Depression Scale) ‐ Augmentation agents Show forest plot	13	310	Std. Mean Difference (IV, Random, 95% CI)	‐0.23 [‐0.70, 0.23]

2.1 antipsychotics	7	192	Std. Mean Difference (IV, Random, 95% CI)	‐0.23 [‐0.88, 0.42]
2.4 Other medications	6	118	Std. Mean Difference (IV, Random, 95% CI)	‐0.24 [‐0.96, 0.49]
3 Hamilton Anxiety Rating Scale (HAM‐A) ‐ Anxiety disorders Show forest plot	7	175	Mean Difference (IV, Random, 95% CI)	‐1.33 [‐4.69, 2.03]

3.1 Panic Disorder	1	25	Mean Difference (IV, Random, 95% CI)	‐6.5 [‐8.86, ‐4.14]
3.2 Obsessive compulsive disorder	6	150	Mean Difference (IV, Random, 95% CI)	‐0.33 [‐3.43, 2.77]
4 Hamilton Anxiety Rating Scale (HAM‐A) ‐ Augmentation agents Show forest plot	7	175	Mean Difference (IV, Random, 95% CI)	‐1.33 [‐4.69, 2.03]

4.1 antipsychotics	2	73	Mean Difference (IV, Random, 95% CI)	‐4.01 [‐8.41, 0.40]
4.4 Other medications	5	102	Mean Difference (IV, Random, 95% CI)	‐0.12 [‐4.79, 4.56]

Comparison 2. Medication vs Placebo: Comorbid symptoms

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Comparison 3. Medication vs Placebo: Quality of Life Scales

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sheehan Disability Scale Show forest plot	3	102	Mean Difference (IV, Random, 95% CI)	‐1.18 [‐2.55, 0.19]

Comparison 3. Medication vs Placebo: Quality of Life Scales

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Comparison 4. Medication vs Placebo: Drop‐out Rate

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Drop‐out rate due to treatment emergent adverse effects Show forest plot	9	241	Risk Ratio (M‐H, Random, 95% CI)	2.16 [0.64, 7.28]

1.1 antipsychotics	7	209	Risk Ratio (M‐H, Random, 95% CI)	3.60 [0.94, 13.70]
1.3 beta‐blockers	1	16	Risk Ratio (M‐H, Random, 95% CI)	0.2 [0.01, 3.61]
1.5 Other medication	1	16	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Medication vs Placebo: Drop‐out Rate

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Comparison 5. Subgroup analyses ‐ Methodological criteria

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5 Industry versus non‐industry funded trials Show forest plot	9	250	Risk Ratio (M‐H, Random, 95% CI)	3.16 [1.08, 9.23]

5.1 Industry funded trials	5	164	Risk Ratio (M‐H, Random, 95% CI)	2.34 [0.61, 8.97]
5.2 Non‐industry funded trials	4	86	Risk Ratio (M‐H, Random, 95% CI)	6.06 [1.50, 24.54]
7 Industry versus non‐industry funded trials Show forest plot	10	255	Std. Mean Difference (IV, Random, 95% CI)	‐0.36 [‐0.69, ‐0.03]

7.1 Industry funded trials	5	151	Std. Mean Difference (IV, Random, 95% CI)	‐0.37 [‐0.90, 0.17]
7.2 Non‐industry funded trials	5	104	Std. Mean Difference (IV, Random, 95% CI)	‐0.40 [‐0.83, 0.03]

Comparison 5. Subgroup analyses ‐ Methodological criteria

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Comparison 6. Subgroup analyses ‐ Clinical criteria

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Inclusion of major depression vs. non‐inclusion: CGI‐I Show forest plot	6	158	Risk Ratio (M‐H, Random, 95% CI)	3.97 [0.75, 20.98]

1.1 Trials including patients with major depressive disorder	4	97	Risk Ratio (M‐H, Random, 95% CI)	9.52 [1.88, 48.21]
1.2 Trials excluding patients with major depressive disorder	2	61	Risk Ratio (M‐H, Random, 95% CI)	1.60 [0.25, 10.38]
2 Inclusion of major depression vs. non‐inclusion Show forest plot	10	242	Std. Mean Difference (IV, Random, 95% CI)	‐0.87 [‐1.35, ‐0.39]

2.1 Trials including patients with major depressive disorder	5	111	Std. Mean Difference (IV, Random, 95% CI)	‐0.83 [‐1.55, ‐0.11]
2.2 Trials excluding patients with major depressive disorder	5	131	Std. Mean Difference (IV, Random, 95% CI)	‐0.92 [‐1.63, ‐0.20]
3 Adequate previous trials versus inadequate trials: CGI‐I Show forest plot	9	250	Risk Ratio (M‐H, Random, 95% CI)	3.16 [1.08, 9.23]

3.1 Validated treatment‐resistant sample	5	123	Risk Ratio (M‐H, Random, 95% CI)	2.63 [0.56, 12.38]
3.2 Non‐validated sample	4	127	Risk Ratio (M‐H, Random, 95% CI)	4.07 [1.41, 11.74]
4 Adequate previous trials versus inadequate trials Show forest plot	13	312	Std. Mean Difference (IV, Random, 95% CI)	‐0.68 [‐1.11, ‐0.25]

4.1 Validated treatment‐resistant sample	9	198	Std. Mean Difference (IV, Random, 95% CI)	‐0.81 [‐1.38, ‐0.24]
4.2 Non‐validated sample	4	114	Std. Mean Difference (IV, Random, 95% CI)	‐0.43 [‐1.12, 0.26]
5 Non‐responders versus partial responders: CGI‐I Show forest plot	8	231	Risk Ratio (M‐H, Random, 95% CI)	3.02 [0.95, 9.56]

5.1 Non‐responder trials	2	81	Risk Ratio (M‐H, Random, 95% CI)	1.58 [0.30, 8.45]
5.2 Partial responder trials	6	150	Risk Ratio (M‐H, Random, 95% CI)	4.87 [1.57, 15.11]
6 Non‐responders versus partial responders Show forest plot	10	248	Std. Mean Difference (IV, Random, 95% CI)	‐0.59 [‐1.07, ‐0.12]

6.1 Non‐responder trials	5	136	Std. Mean Difference (IV, Random, 95% CI)	‐0.70 [‐1.24, ‐0.17]
6.2 Partial responder trials	5	112	Std. Mean Difference (IV, Random, 95% CI)	‐0.45 [‐1.32, 0.42]

Comparison 6. Subgroup analyses ‐ Clinical criteria

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